Clinical trials
TroFuse-033
Identifier
NCT06952504
Link
https://clinicaltrials.gov/study/NCT06952504
Phase
Phase III
Status
Not yet recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
* EC is a type of cancer that starts in the tissues inside the uterus (womb)
* pMMR indicates that certain normal proteins are present in the cancer cells
* Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
* Recurrent means the cancer came back after surgery
Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goal of this study is to learn if people who receive sac-TMT with pembrolizuma
Purpose
A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Can
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-05-23
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-04-23
Estimated Primary Completion Date
2032-05-24
Estimated Completion Date
2032-05-24
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key inclusion criteria include but are not limited to:
* Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
* Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
* Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1123
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
DESTINY-Lung06
Identifier
NCT06899126
Link
https://clinicaltrials.gov/study/NCT06899126
Phase
Phase III
Status
Not yet recruiting
Sponsor
Daiichi Sankyo
More details
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
Purpose
Study of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Pembrolizumab With Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-09-07
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-03-21
Estimated Primary Completion Date
2030-03-05
Estimated Completion Date
2032-07-05
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.
Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
3. Histologically documented non-squamous locally advanced unresectable or metastatic
NSCLC and meets all of the following criteria:
Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
686
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
2870-011
Identifier
NCT06841354
Link
https://clinicaltrials.gov/study/NCT06841354
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
Purpose
A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
Interventions
Not provided
Countries
United States of America
Israel
Taiwan, Province of China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-03-16
Anticipated Date of Last Follow-up
2025-04-24
Estimated Primary Completion Date
2030-05-18
Estimated Completion Date
2030-05-18
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
* Has not received systemic treatment for locally recurrent unresectable or metastatic TNBC
* Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
* Is a candidate for treatment with one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-relate
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1000
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
DS8201-724
Identifier
NCT06731478
Link
https://clinicaltrials.gov/study/NCT06731478
Phase
Phase III
Status
Recruiting
Sponsor
Daiichi Sankyo
More details
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.
Purpose
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Interventions
Not provided
Countries
Japan
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-02-27
Anticipated Date of Last Follow-up
2025-04-09
Estimated Primary Completion Date
2028-06-01
Estimated Completion Date
2030-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion
1. Sign and date the Tissue Prescreening ICF, prior to HER2 and PD-L1 CPS central testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.
2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and/or adjuvant setting is permissible, provided there is \>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
726
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
3475A-F84
Identifier
NCT06698042
Link
https://clinicaltrials.gov/study/NCT06698042
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.
Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Purpose
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Interventions
Not provided
Countries
United States of America
China
Guatemala
Japan
Korea, Republic of
Peru
Poland
Romania
Spain
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-11-21
Anticipated Date of Last Follow-up
2025-04-24
Estimated Primary Completion Date
2026-06-22
Estimated Completion Date
2030-02-11
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.
Exclusion Criteria:
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
160
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
V940-009
Identifier
NCT06623422
Link
https://clinicaltrials.gov/study/NCT06623422
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to learn if people who receive V940 and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving V940 and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Purpose
A Study of Pembrolizumab (MK-3475) With or Without V940 in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Brazil
Canada
Chile
Colombia
Israel
Japan
Korea, Republic of
Singapore
Taiwan, Province of China
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-10-21
Anticipated Date of Last Follow-up
2025-04-24
Estimated Primary Completion Date
2033-05-16
Estimated Completion Date
2038-01-26
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tum
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
680
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
EF-41
Identifier
NCT06556563
Link
https://clinicaltrials.gov/study/NCT06556563
Phase
Phase III
Status
Recruiting
Sponsor
NovoCure GmbH
More details
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
Purpose
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Interventions
Not provided
Countries
United States of America
France
Israel
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-02-03
Anticipated Date of Last Follow-up
2025-04-22
Estimated Primary Completion Date
2029-04-01
Estimated Completion Date
2029-04-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. The participant (or legally acceptable representative) has provided documented informed consent for the study.
2. Be ≥ 18 years of age on day of providing informed consent.
3. Participant with new diagnosis of GBM according to World Health Organization (WHO) 2021 Classification.
4. Recovered from maximal debulking surgery (gross total resection, partial resection and biopsy-only patients are all acceptable), Gliadel wafers placement at the time of surgical resection is allowed.
5. Have completed standard adjuvant chemoradiotherapy of radiotherapy (RT) according to local practice (56-64 Gy), and concomitant TMZ chemotherapy.
6. Amenable to treatment with Optune concomitant with maintenance TMZ (150-200 mg/m\^2 daily x 5, Q28 days).
7. Have an Eastern Cooperative Onco
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
741
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
2870-023
Identifier
NCT06422143
Link
https://clinicaltrials.gov/study/NCT06422143
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
Purpose
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Interventions
Not provided
Countries
United States of America
Argentina
Austria
Brazil
Canada
Chile
China
Colombia
Czechia
France
Germany
Hungary
Ireland
Israel
Italy
Japan
Korea, Republic of
Peru
Poland
Romania
Spain
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-06-10
Anticipated Date of Last Follow-up
2025-04-16
Estimated Primary Completion Date
2029-01-12
Estimated Completion Date
2031-02-12
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]
* Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
* Has life expectancy ≥3 months
* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
851
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
1084-004
Identifier
NCT06345729
Link
https://clinicaltrials.gov/study/NCT06345729
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Purpose
A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Austria
Brazil
Bulgaria
Canada
Chile
China
France
Georgia
Greece
Italy
Japan
Korea, Republic of
Mexico
Netherlands
New Zealand
Philippines
Romania
Spain
Türkiye
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-05-24
Anticipated Date of Last Follow-up
2025-04-24
Estimated Primary Completion Date
2029-02-19
Estimated Completion Date
2031-02-18
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of NSCLC
* Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
* Has measurable disease based on RECIST 1.1
* Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells
* Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
* Has life expectancy of at least 3 months
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatme
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
600
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
2870-010
Identifier
NCT06312176
Link
https://clinicaltrials.gov/study/NCT06312176
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Purpose
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locall
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
Costa Rica
Czechia
Denmark
France
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Netherlands
New Zealand
Peru
Poland
Portugal
Puerto Rico
Romania
Singapore
South Africa
Spain
Sweden
Switzerland
Taiwan, Province of China
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-04-14
Anticipated Date of Last Follow-up
2025-04-24
Estimated Primary Completion Date
2027-07-11
Estimated Completion Date
2031-04-12
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1200
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 6 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
TroFuse-019
Identifier
NCT06312137
Link
https://clinicaltrials.gov/study/NCT06312137
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Purpose
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Patholo
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Czechia
France
Germany
Greece
Hong Kong
Israel
Italy
Japan
Korea, Republic of
Mexico
Netherlands
New Zealand
Norway
Peru
Poland
Portugal
Romania
Spain
Switzerland
Taiwan, Province of China
Türkiye
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-04-03
Anticipated Date of Last Follow-up
2025-04-30
Estimated Primary Completion Date
2034-02-21
Estimated Completion Date
2034-10-23
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines
* Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy
* Is able to undergo surgery based on opinion of investigator after consultation with surgeon
* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy
* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete respons
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
780
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 2 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
V940-007
Identifier
NCT06295809
Link
https://clinicaltrials.gov/study/NCT06295809
Phase
Phase II/III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC
Purpose
A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007).
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
Czechia
France
Germany
Hungary
Israel
Italy
New Zealand
Norway
Poland
Romania
Spain
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-04-18
Anticipated Date of Last Follow-up
2025-01-28
Estimated Primary Completion Date
2026-03-05
Estimated Completion Date
2026-03-05
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically confirmed diagnosis of resectable cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted).
* Has LA Stage II-IV (M0) cSCC without distant metastases.
* cSCC must be amenable to surgery (resectable) with curative intent.
* Has a formalin-fixed, paraffin-embedded (FFPE) tumor sample available or is able to provide one that is suitable for the Next-generation Sequencing (NGS) required for this study.
* For males, agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving adjuvant radiation therapy (RT), and for ≥3 months after the last dose of study intervention
* Is female and not pregnant/
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1012
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
TroFuse-007
Identifier
NCT06170788
Link
https://clinicaltrials.gov/study/NCT06170788
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.
All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Purpose
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Propor
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Brazil
Canada
Chile
China
Colombia
Czechia
Denmark
France
Germany
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Peru
Poland
Portugal
Spain
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Viet Nam
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-12-15
Anticipated Date of Last Follow-up
2025-04-30
Estimated Primary Completion Date
2028-01-25
Estimated Completion Date
2030-05-27
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
* Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
* Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
* A life expectancy of at least 3 months.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion C
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
614
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
V940-001
Identifier
NCT05933577
Link
https://clinicaltrials.gov/study/NCT05933577
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
Purpose
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Belgium
Brazil
Canada
Chile
Colombia
Denmark
France
Germany
Greece
Israel
Italy
Japan
Korea, Republic of
New Zealand
Poland
Portugal
South Africa
Spain
Sweden
Switzerland
Taiwan, Province of China
Türkiye
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-19
Anticipated Date of Last Follow-up
2024-11-14
Estimated Primary Completion Date
2029-10-26
Estimated Completion Date
2030-09-26
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
* Has not received any prior systemic therapy for their melanoma beyond surgical resection
* No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
* Is disease free at the time of providing documented consent for the study
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has ocular or mucosal melanoma
* Has
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1089
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 6 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
SGNDV-001
Identifier
NCT05911295
Link
https://clinicaltrials.gov/study/NCT05911295
Phase
Phase III
Status
Recruiting
Sponsor
Seagen Inc.
More details
This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This study will try to find out if the drugs disitamab vedotin with pembrolizumab works better than platinum-containing chemotherapy to treat patients with UC. This study will also test what side effects happen when participants take these drugs together. A side effect is anything a drug does to the body besides treating the disease.
Participants in this study will have cancer that has spread through the body (metastatic) or spread near where it started (locally advanced).
In this study, there are 2 different groups. Participants will be assigned to a group randomly. Participants in the disitamab vedotin arm will ge
Purpose
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Brazil
Canada
Chile
France
Israel
Italy
Korea, Republic of
Peru
Singapore
Spain
Taiwan, Province of China
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-09-22
Anticipated Date of Last Follow-up
2025-02-19
Estimated Primary Completion Date
2026-06-30
Estimated Completion Date
2029-04-30
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra.
* Measurable disease by investigator assessment per RECIST v1.1.
* Participant must not have received prior systemic therapy for LA/mUC. Exception will be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression occurred more than 12 months after the last dose of therapy.
* Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
* Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to treatment initiation. If archival tissue is not available a ne
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
400
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"every 6 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
6482-012 China Extension
Identifier
NCT05899049
Link
https://clinicaltrials.gov/study/NCT05899049
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this China extension study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in Chinese participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Purpose
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenva
Interventions
Not provided
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-07-27
Anticipated Date of Last Follow-up
2024-06-20
Estimated Primary Completion Date
2026-12-01
Estimated Completion Date
2026-12-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of RCC with clear cell component.
* Has received no prior systemic therapy for advanced ccRCC
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
* Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
* Has adequately controlled bloo
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
249
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"Q6W
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
7684A-010
Identifier
NCT05665595
Link
https://clinicaltrials.gov/study/NCT05665595
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.
Purpose
A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Colombia
France
Germany
India
Ireland
Israel
Italy
Japan
Korea, Republic of
New Zealand
Poland
South Africa
Spain
Sweden
Switzerland
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-01-19
Anticipated Date of Last Follow-up
2025-04-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-08-27
Actual Primary Completion Date
2024-03-06
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
* Has not received any prior systemic therapy for melanoma beyond surgical resection
* Has had no more than 12 weeks between final surgical resection and randomization
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1594
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Implant
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
DS1062-A-U303
Identifier
NCT05555732
Link
https://clinicaltrials.gov/study/NCT05555732
Phase
Phase III
Status
Recruiting
Sponsor
Daiichi Sankyo
More details
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Purpose
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
China
Czechia
France
Germany
Greece
Hong Kong
Hungary
Italy
Japan
Korea, Republic of
Mexico
Netherlands
Poland
Portugal
Romania
Spain
Switzerland
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-01-11
Anticipated Date of Last Follow-up
2025-04-18
Estimated Primary Completion Date
2027-08-01
Estimated Completion Date
2027-08-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old).
3. Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been rando
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1170
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
7902-010 China Extension
Identifier
NCT05523323
Link
https://clinicaltrials.gov/study/NCT05523323
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.
Hypotheses include:
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Purpose
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastat
Interventions
Not provided
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-10-30
Anticipated Date of Last Follow-up
2025-04-11
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-08-25
Actual Completion Date
2025-03-28
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV
* Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
112
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
3475-C66
Identifier
NCT05239741
Link
https://clinicaltrials.gov/study/NCT05239741
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.
Purpose
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
Interventions
Not provided
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-04-02
Anticipated Date of Last Follow-up
2025-03-20
Estimated Primary Completion Date
2028-09-19
Estimated Completion Date
2028-09-19
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
* Has a histologically confirmed diagnosis of colorectal adenocarcinoma that is at stage IV (as defined by American Joint Committee on Cancer eighth edition) \[National Comprehensive Cancer Network 2018\]
* Has centrally confirmed Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) status
* Has centrally confirmed RAS and BRAF mutation status
* A woman of child-bearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention.
* Has measurable disease
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
100
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
6482-022
Identifier
NCT05239728
Link
https://clinicaltrials.gov/study/NCT05239728
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.
The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).
Purpose
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
Interventions
Not provided
Countries
United States of America
Australia
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czechia
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Netherlands
New Zealand
Poland
Romania
Singapore
Spain
Sweden
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-15
Anticipated Date of Last Follow-up
2025-01-17
Estimated Primary Completion Date
2026-10-28
Estimated Completion Date
2029-09-28
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
* Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1800
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 6 weeks (Q6W)
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
KEYVIBE-006
Identifier
NCT05298423
Link
https://clinicaltrials.gov/study/NCT05298423
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
Purpose
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Par
Interventions
Not provided
Countries
United States of America
Argentina
Australia
Brazil
Chile
China
Costa Rica
Czechia
Dominican Republic
Germany
Greece
Guatemala
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Philippines
Portugal
Romania
South Africa
Spain
Türkiye
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-05-03
Anticipated Date of Last Follow-up
2025-03-27
Estimated Primary Completion Date
2026-08-19
Estimated Completion Date
2026-08-19
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
* Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
* Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
* Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
* Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
* Has measurable disease as defined by RECIST 1.1, with at lea
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
611
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
7684A-007
Identifier
NCT05226598
Link
https://clinicaltrials.gov/study/NCT05226598
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
Purpose
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684
Interventions
Not provided
Countries
United States of America
Argentina
Austria
Brazil
Chile
Colombia
France
Germany
Israel
Japan
Korea, Republic of
Mexico
Poland
Spain
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-24
Anticipated Date of Last Follow-up
2025-02-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-01-09
Actual Primary Completion Date
2024-09-24
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
* Has not received prior systemic treatment for metastatic NSCLC
* Has measurable disease based on RECIST 1.1, as determined by the local site assessment
* Has a life expectancy of at least 3 months
* Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method
Exclusion Criteria:
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Severe hypersensitivity to M
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
739
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
3475-C93
Identifier
NCT05173987
Link
https://clinicaltrials.gov/study/NCT05173987
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.
The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
Purpose
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-02-03
Anticipated Date of Last Follow-up
2024-11-19
Estimated Primary Completion Date
2027-05-27
Estimated Completion Date
2027-05-27
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
* Has received no prior systemic therapy for EC except for the following:
1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurren
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
280
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-B96
Identifier
NCT05116189
Link
https://clinicaltrials.gov/study/NCT05116189
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as ass
Purpose
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-12-13
Anticipated Date of Last Follow-up
2025-03-05
Estimated Primary Completion Date
2025-06-30
Estimated Completion Date
2028-10-25
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
* Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
* Has provided documented informed consent for the study.
* Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., p
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
616
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
ASCENT-04
Identifier
NCT05382286
Link
https://clinicaltrials.gov/study/NCT05382286
Phase
Phase III
Status
Not provided
Sponsor
Gilead Sciences
More details
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Purpose
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-N
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-07-25
Anticipated Date of Last Follow-up
2024-12-19
Estimated Primary Completion Date
2027-02-01
Estimated Completion Date
2027-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
443
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
IO102-IO103-013 / KEYNOTE-D18
Identifier
NCT05155254
Link
https://clinicaltrials.gov/study/NCT05155254
Phase
Phase III
Status
Not provided
Sponsor
IO Biotech
More details
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.
Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.
All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103
Purpose
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
Interventions
Not provided
Countries
United States of America
Australia
Belgium
Czechia
Denmark
Germany
Hungary
Israel
Italy
Netherlands
Poland
South Africa
Spain
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-05-17
Anticipated Date of Last Follow-up
2024-01-08
Estimated Primary Completion Date
2025-07-01
Estimated Completion Date
2027-09-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy
2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:
1. Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigators assessment. Documented BRAF V600 mutation status must be available from all patients prior to trial entry.
2. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
407
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-014
Identifier
NCT04949256
Link
https://clinicaltrials.gov/study/NCT04949256
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Interventions
Not provided
Countries
United States of America
Argentina
Canada
Chile
China
Costa Rica
Denmark
France
Guatemala
Hong Kong
Hungary
Italy
Japan
Korea, Republic of
Taiwan, Province of China
Thailand
Türkiye
Ukraine
United Kingdom
Malaysia
Romania
Russian Federation
Singapore
South Africa
Spain
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-07-28
Anticipated Date of Last Follow-up
2025-03-05
Estimated Primary Completion Date
2027-01-31
Estimated Completion Date
2027-01-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
* Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual li
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
862
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
TACTI-004
Identifier
NCT06726265
Link
https://clinicaltrials.gov/study/NCT06726265
Phase
Phase III
Status
Recruiting
Sponsor
Immutep S.A.S.
More details
The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).
Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.
Purpose
Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lun
Interventions
Intervention 1
eftilagimod alfa
Intervention 2
carboplatin plus paclitaxel
Intervention 3
cisplatin or carboplatin + pemetrexed
Intervention 4
Pembrolizumab (KEYTRUDA®)
Intervention 5
Placebo
Countries
Australia
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-03-21
Anticipated Date of Last Follow-up
2025-03-27
Estimated Primary Completion Date
2027-06-01
Estimated Completion Date
2029-09-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
Participants may be enrolled if they meet all of the following criteria at screening:
1. Willing to give written informed consent and to comply with the protocol.
2. Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) non-small cell lung cancer (NSCLC) not amenable to curative treatment or locally available oncogenic driver mutation-based first-line therapy, treatment naïve for systemic therapy given for advanced/metastatic disease.
3. Archival tumor tissue sample or newly obtained core, or excisional biopsy of a tumor lesion not previously irradiated has been provided. Details pertaining to tumor tissue submission can be found in the Laboratory Manual.
4. Availability of programmed death-ligand 1 (PD-L1) biomarker
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
756
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Other
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
KEYVIBE-006
Identifier
NCT05298423
Link
https://clinicaltrials.gov/study/NCT05298423
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
Purpose
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Par
Interventions
Intervention 1
pembrolizumab/vibostolimab
Intervention 2
durvalumab
Intervention 3
cisplatin
Intervention 4
pemetrexed
Intervention 5
etoposide
Countries
United States of America
Argentina
Australia
Brazil
Chile
China
Costa Rica
Czechia
Dominican Republic
Germany
Greece
Guatemala
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Philippines
Portugal
Romania
South Africa
Spain
Türkiye
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-05-03
Anticipated Date of Last Follow-up
2025-03-27
Estimated Primary Completion Date
2026-08-19
Estimated Completion Date
2026-08-19
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
* Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
* Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
* Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
* Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
* Has measurable disease as defined by RECIST 1.1, with at lea
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
611
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7684A-007
Identifier
NCT05226598
Link
https://clinicaltrials.gov/study/NCT05226598
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).
Purpose
Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684
Interventions
Intervention 1
Pembrolizumab/Vibostolimab
Intervention 2
Carboplatin
Intervention 3
Cisplatin
Intervention 4
Paclitaxel
Intervention 5
Nab-paclitaxel
Countries
United States of America
Argentina
Austria
Brazil
Chile
China
Colombia
France
Germany
Israel
Japan
Korea, Republic of
Mexico
Poland
Spain
Taiwan, Province of China
Thailand
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-24
Anticipated Date of Last Follow-up
2025-02-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-01-09
Actual Primary Completion Date
2024-09-24
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
* Has not received prior systemic treatment for metastatic NSCLC
* Has measurable disease based on RECIST 1.1, as determined by the local site assessment
* Has a life expectancy of at least 3 months
* Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method
Exclusion Criteria:
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Severe hypersensitivity to M
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
739
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-C93
Identifier
NCT05173987
Link
https://clinicaltrials.gov/study/NCT05173987
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.
The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
Purpose
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
Interventions
Intervention 1
pembrolizumab
Intervention 2
carboplatin
Intervention 3
paclitaxel
Intervention 4
docetaxel
Intervention 5
cisplatin
Countries
United States of America
Australia
Belgium
Brazil
Canada
Chile
Taiwan, Province of China
Czechia
Denmark
Finland
Germany
Hungary
Ireland
Israel
Italy
Japan
Korea, Republic of
Netherlands
New Zealand
Russian Federation
Poland
Norway
Spain
Sweden
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-02-03
Anticipated Date of Last Follow-up
2024-11-19
Estimated Primary Completion Date
2027-05-27
Estimated Completion Date
2027-05-27
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
* Has received no prior systemic therapy for EC except for the following:
1. May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurren
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
280
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
ASCENT-04
Identifier
NCT05382286
Link
https://clinicaltrials.gov/study/NCT05382286
Phase
Phase III
Status
Not provided
Sponsor
Gilead Sciences
More details
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Purpose
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-N
Interventions
Intervention 1
Sacituzumab Govitecan-hziy
Intervention 2
Pembrolizumab
Intervention 3
Paclitaxel
Intervention 4
nab-Paclitaxel
Intervention 5
Gemcitabine
Countries
United States of America
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
Czechia
Germany
Hong Kong
Hungary
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Netherlands
Poland
Puerto Rico
South Africa
Spain
Switzerland
Taiwan, Province of China
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-07-25
Anticipated Date of Last Follow-up
2024-12-19
Estimated Primary Completion Date
2027-02-01
Estimated Completion Date
2027-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
443
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
IO102-IO103-013 / KEYNOTE-D18
Identifier
NCT05155254
Link
https://clinicaltrials.gov/study/NCT05155254
Phase
Phase III
Status
Not provided
Sponsor
IO Biotech
More details
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.
Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.
All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103
Purpose
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
Interventions
Intervention 1
IO102-IO103
Intervention 2
Pembrolizumab
Countries
United States of America
Australia
Belgium
Czechia
Denmark
France
Germany
Hungary
Israel
Italy
Netherlands
Poland
South Africa
Spain
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-05-17
Anticipated Date of Last Follow-up
2024-01-08
Estimated Primary Completion Date
2025-07-01
Estimated Completion Date
2027-09-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy
2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:
1. Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigators assessment. Documented BRAF V600 mutation status must be available from all patients prior to trial entry.
2. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
407
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-A86
Identifier
NCT04956692
Link
https://clinicaltrials.gov/study/NCT04956692
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.
Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up t
Purpose
Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Sma
Interventions
Intervention 1
Pembrolizumab SC
Intervention 2
Pembrolizumab IV
Intervention 3
Paclitaxel
Intervention 4
Nab-Paclitaxel
Intervention 5
Carboplatin
Countries
United States of America
Brazil
France
Guatemala
Hungary
Japan
Korea, Republic of
Peru
Poland
Romania
Russian Federation
South Africa
Spain
Taiwan, Province of China
Türkiye
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-08-05
Anticipated Date of Last Follow-up
2024-11-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-10-14
Actual Primary Completion Date
2023-04-04
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
* Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
* Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
* Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
531
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-014
Identifier
NCT04949256
Link
https://clinicaltrials.gov/study/NCT04949256
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Cisplatin
Intervention 4
5-FU
Intervention 5
Oxaliplatin
Countries
United States of America
Argentina
Canada
Chile
China
Costa Rica
France
Guatemala
Hong Kong
Hungary
Italy
Japan
Korea, Republic of
Malaysia
Romania
Russian Federation
Singapore
South Africa
Spain
Taiwan, Province of China
Thailand
Türkiye
Ukraine
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-07-28
Anticipated Date of Last Follow-up
2025-03-05
Estimated Primary Completion Date
2027-01-31
Estimated Completion Date
2027-01-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
* Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual li
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
862
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-991 China Extension
Identifier
NCT04934722
Link
https://clinicaltrials.gov/study/NCT04934722
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in Chinese participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of Amendment 4, the study is being stopped for futility. All the prespecified interim analysis after interim analysis (IA1) and final analysis of the study described the statistical analysis plan (SA
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Pro
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Enzalutamide
Intervention 3
Androgen Deprivation Therapy (ADT)
Intervention 4
Placebo
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-05-25
Anticipated Date of Last Follow-up
2025-02-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-09-30
Actual Primary Completion Date
2022-10-31
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Willing to maintain continuous Androgen Deprivation Therapy (ADT) with a luteinizing-hormone releasing hormone (LHRH) agonists or antagonists during study treatment or have a history of bilateral orchiectomy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
186
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-966 China Extension
Identifier
NCT04924062
Link
https://clinicaltrials.gov/study/NCT04924062
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Purpose
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China E
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Gemcitabine
Intervention 3
Cisplatin
Intervention 4
Placebo
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-07-10
Anticipated Date of Last Follow-up
2025-04-09
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-12-15
Actual Completion Date
2025-03-25
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function
Exclusion Criteria
* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
158
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-921 China Extension
Identifier
NCT04907227
Link
https://clinicaltrials.gov/study/NCT04907227
Phase
Phase III
Status
Terminated
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified
Purpose
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-09-23
Anticipated Date of Last Follow-up
2024-06-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-08-03
Actual Completion Date
2023-07-18
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
* Has ongoing androgen depri
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
81
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-B49
Identifier
NCT04895358
Link
https://clinicaltrials.gov/study/NCT04895358
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1.
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Interventions
Intervention 1
pembrolizumab
Intervention 2
paclitaxel
Intervention 3
nab-paclitaxel
Intervention 4
liposomal doxorubicin
Intervention 5
capecitabine
Countries
United States of America
Australia
Austria
Brazil
Canada
Chile
China
Colombia
France
Germany
Greece
Guatemala
Hungary
Ireland
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Netherlands
Philippines
Poland
Portugal
Romania
Russian Federation
Spain
Sweden
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-06-18
Anticipated Date of Last Follow-up
2025-02-27
Estimated Primary Completion Date
2027-12-18
Estimated Completion Date
2027-12-18
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
* Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
* Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
* GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metas
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
340
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-585 China Extension
Identifier
NCT04882241
Link
https://clinicaltrials.gov/study/NCT04882241
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated Chinese adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. No formal hypothesis testing will be done.
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Exten
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
Capecitabine
Intervention 5
5-fluorouracil
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-07-29
Anticipated Date of Last Follow-up
2025-02-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-04-23
Actual Primary Completion Date
2024-02-16
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has previously untreated localized gastric or gastroesophageal junction (GEJ) adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
* Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
* Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the las
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
120
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
ARTISTRY-7
Identifier
NCT05092360
Link
https://clinicaltrials.gov/study/NCT05092360
Phase
Phase III
Status
Not provided
Sponsor
Mural Oncology, Inc
More details
This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Purpose
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Interventions
Intervention 1
Nemvaleukin and Pembrolizumab Combination
Intervention 2
Pembrolizumab
Intervention 3
Nemvaleukin
Intervention 4
Pegylated Liposomal Doxorubicin (PLD)
Intervention 5
Paclitaxel
Countries
United States of America
Australia
Austria
Belgium
Canada
Czechia
France
Germany
Italy
Korea, Republic of
Singapore
Spain
Taiwan, Province of China
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-01-10
Anticipated Date of Last Follow-up
2024-06-27
Estimated Primary Completion Date
2026-05-01
Estimated Completion Date
2027-05-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Patient is female and ≥18 years of age.
* Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
* Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
* Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of sy
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
456
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Single blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
LEAP-001
Identifier
NCT04865289
Link
https://clinicaltrials.gov/study/NCT04865289
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).
As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combinati
Purpose
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study
Interventions
Intervention 1
Lenvatinib
Intervention 2
Pembrolizumab
Intervention 3
Paclitaxel
Intervention 4
Carboplatin
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-10-22
Anticipated Date of Last Follow-up
2025-01-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-02
Actual Completion Date
2025-01-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determinati
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
130
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-859 China Extension
Identifier
NCT04859582
Link
https://clinicaltrials.gov/study/NCT04859582
Phase
Phase III
Status
Withdrawn
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants.
The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Purpose
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Cisplatin
Intervention 3
5-fluorouracil
Intervention 4
Oxaliplatin
Intervention 5
Capecitabine
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-11-08
Anticipated Date of Last Follow-up
2021-12-15
Estimated Primary Completion Date
2024-11-29
Estimated Completion Date
2024-11-29
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status
* Has human epidermal growth factor receptor 2 (HER2) negative cancer
* Male participants must agree to use contraception during the intervention period and for at least 95 days after the last dose of chemotherapy, refrain from donating sperm and be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period
* Female participants who are not pregnant, not breastfeeding, and at least one of
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-017
Identifier
NCT04776148
Link
https://clinicaltrials.gov/study/NCT04776148
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride).
The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.
Purpose
Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)
Interventions
Intervention 1
pembrolizumab
Intervention 2
lenvatinib
Intervention 3
regorafenib
Intervention 4
TAS-102 (trifluridine and tipiracil)
Countries
United States of America
Argentina
Australia
Canada
China
Denmark
Germany
Japan
Korea, Republic of
Russian Federation
Spain
Taiwan, Province of China
Türkiye
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-03-29
Anticipated Date of Last Follow-up
2024-10-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-02-20
Actual Completion Date
2024-09-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma (Stage IV A, B and C as defined by American Joint Committee on Cancer \[AJCC\] 8th edition). Note: Tumor must be determined to be NOT microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) by local testing
* Has been previously treated for their disease and has shown disease progression as defined by RECIST 1.1 on or after or could not tolerate standard treatment, which must include ALL of the following agents if approved and locally available in the country where the participant is randomized:
1. fluoropyrimidine, irinotecan and oxaliplatin
2. with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bev
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
480
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7684A-003
Identifier
NCT04738487
Link
https://clinicaltrials.gov/study/NCT04738487
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.
* Metastatic means cancer that has spread to other parts of the body.
* PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system.
The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
Purpose
Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-
Interventions
Intervention 1
Pembrolizumab/Vibostolimab
Intervention 2
Pembrolizumab
Countries
United States of America
Brazil
Canada
Chile
China
Dominican Republic
Guatemala
Hong Kong
Hungary
India
Japan
Korea, Republic of
Malaysia
Mexico
Peru
Philippines
Romania
Russian Federation
South Africa
Thailand
Türkiye
Ukraine
Viet Nam
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-04-07
Anticipated Date of Last Follow-up
2025-03-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2024-09-05
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
* Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
* Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
* H
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1264
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
6482-012
Identifier
NCT04736706
Link
https://clinicaltrials.gov/study/NCT04736706
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Purpose
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and L
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Belzutifan
Intervention 3
Pembrolizumab/Quavonlimab
Intervention 4
Lenvatinib
Countries
United States of America
Australia
Brazil
Canada
Chile
China
Colombia
Croatia
Czechia
Denmark
Finland
France
Germany
Guatemala
Hungary
Ireland
Italy
Japan
Malaysia
Mexico
Norway
United Kingdom
Ukraine
Türkiye
Thailand
Taiwan, Province of China
Sweden
Spain
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-04-14
Anticipated Date of Last Follow-up
2024-11-14
Estimated Primary Completion Date
2026-10-29
Estimated Completion Date
2026-10-29
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of RCC with clear cell component.
* Has received no prior systemic therapy for advanced ccRCC
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib.
* Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
* Has adequately controlled bloo
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1653
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-006 China Extension
Identifier
NCT04716933
Link
https://clinicaltrials.gov/study/NCT04716933
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pemetrexed+platinum chemotherapy+pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults from mainland China with metastatic nonsquamous non-small cell lung cancer.
The primary study hypotheses state that: 1) the combination of lenvatinib+platinum doublet chemotherapy+pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo+platinum doublet chemotherapy+pembrolizumab, and 2) the combination of lenvatinib+platinum doublet chemotherapy+pembrolizumab prolongs Overall Survival (OS) compared to matching placebo+platin
Purpose
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous No
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Cisplatin
Intervention 4
Pemetrexed
Intervention 5
Lenvatinib
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-11-05
Anticipated Date of Last Follow-up
2024-09-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-08-11
Actual Completion Date
2024-08-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer \[AJCC\], version 8 or current version) nonsquamous NSCLC.
* Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
* Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the com
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
201
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYNOTE-B15
Identifier
NCT04700124
Link
https://clinicaltrials.gov/study/NCT04700124
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy \[gemcitabine plus cisplatin\] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The primary hypothesis is perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).
Purpose
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Enfortumab vedotin (EV)
Intervention 3
RC + PLND
Intervention 4
Gemcitabine
Intervention 5
Cisplatin
Countries
United States of America
Argentina
Australia
Bulgaria
Canada
China
Colombia
Croatia
Czechia
France
Germany
Greece
Hungary
Israel
Italy
Japan
Korea, Republic of
Malaysia
Philippines
Poland
Portugal
Romania
Russian Federation
Singapore
South Africa
Spain
Taiwan, Province of China
Ukraine
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-04-21
Anticipated Date of Last Follow-up
2024-12-19
Estimated Primary Completion Date
2026-12-23
Estimated Completion Date
2026-12-23
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have adequate organ function.
Exclusion Criteria:
* Has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions
* Has received any prior systemic treatment for
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
808
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-007
Identifier
NCT03829332
Link
https://clinicaltrials.gov/study/NCT03829332
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Purpose
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Placebo for lenvatinib
Countries
Ukraine
Türkiye
Taiwan, Province of China
United States of America
Russian Federation
Poland
Mexico
Malaysia
Korea, Republic of
Japan
Italy
Israel
Hungary
France
Estonia
Colombia
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-03-13
Anticipated Date of Last Follow-up
2025-03-26
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-05-19
Actual Completion Date
2024-04-24
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Has Stage IV NSCLC (American Joint Committee on Cancer \[AJCC 8th edition\])
* Has measurable disease based on RECIST 1.1
* Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score \[TPS\] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory
* Has a life expectancy of ≥3 months
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization
* Male participants must agree to the following during the treatment period and for ≥7 days after the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
623
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
LEAP-015
Identifier
NCT04662710
Link
https://clinicaltrials.gov/study/NCT04662710
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.
The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Purpose
Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LE
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Oxaliplatin
Intervention 4
Capecitabine
Intervention 5
Leucovorin (or Levoleucovorin)
Countries
United States of America
Argentina
Australia
Belgium
Canada
Chile
China
Colombia
Costa Rica
France
Germany
Guatemala
Hong Kong
Ireland
Israel
Italy
Japan
Korea, Republic of
Poland
Russian Federation
Spain
Taiwan, Province of China
United Kingdom
Türkiye
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-12-30
Anticipated Date of Last Follow-up
2025-02-05
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-03-31
Actual Primary Completion Date
2024-10-29
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
* Is not expected to require tumor resection during the treatment course
* Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
* Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
* Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
* Female participan
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
895
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
C4221016
Identifier
NCT04657991
Link
https://clinicaltrials.gov/study/NCT04657991
Phase
Phase III
Status
Not provided
Sponsor
Pfizer
More details
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that:
* is advanced or metastatic (spread to other parts of the body);
* has a certain type of abnormal gene called "BRAF"; and
* has not received prior treatment.
All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day.
Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team w
Purpose
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Interventions
Intervention 1
Encorafenib
Intervention 2
Binimetinib
Intervention 3
Pembrolizumab
Countries
United States of America
Argentina
Austria
Belgium
Brazil
Bulgaria
Canada
Czechia
Finland
France
Germany
Greece
Hungary
Israel
Italy
Mexico
New Zealand
Norway
Poland
Russian Federation
Slovakia
South Africa
Spain
Switzerland
Ukraine
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-01-15
Anticipated Date of Last Follow-up
2025-04-09
Estimated Primary Completion Date
2025-09-22
Estimated Completion Date
2025-12-30
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male or female participants ≥ 18 years at the time of informed consent.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
* Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1.
* ECOG performance status 0 or 1.
* Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked \[European conformity\] in vitro diagnos
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
256
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-B21
Identifier
NCT04634877
Link
https://clinicaltrials.gov/study/NCT04634877
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Purpose
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Placebo for pembrolizumab
Intervention 5
Docetaxel
Countries
United States of America
Argentina
Austria
Belgium
Canada
Chile
China
Colombia
Czechia
Denmark
Finland
Greece
Israel
Italy
Japan
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-01-10
Anticipated Date of Last Follow-up
2025-02-14
Estimated Primary Completion Date
2026-05-31
Estimated Completion Date
2026-05-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
* Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
* Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
* Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
* Has not receiv
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
990
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-B21
Identifier
NCT04634877
Link
https://clinicaltrials.gov/study/NCT04634877
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Purpose
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Placebo for pembrolizumab
Intervention 5
Docetaxel
Countries
United States of America
Argentina
Austria
Belgium
Canada
Chile
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-01-10
Anticipated Date of Last Follow-up
2025-02-14
Estimated Primary Completion Date
2026-05-31
Estimated Completion Date
2026-05-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
* Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
* Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
* Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
* Has not receiv
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
990
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-B21
Identifier
NCT04634877
Link
https://clinicaltrials.gov/study/NCT04634877
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Purpose
Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Placebo for pembrolizumab
Intervention 5
Docetaxel
Countries
United States of America
Argentina
Austria
Belgium
Canada
Chile
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-01-10
Anticipated Date of Last Follow-up
2025-02-14
Estimated Primary Completion Date
2026-05-31
Estimated Completion Date
2026-05-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
* Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
* Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
* Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
* Has not receiv
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
990
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
MK-7339-012/KEYLYNK-012
Identifier
EUCT2023-503591-25-00
Link
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2023-503591-25-00
Phase
Phase III
Status
Not provided
Sponsor
Not provided
More details
Not provided
Purpose
Not provided
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Unspecified
Genders
Unspecified
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Unspecified
Comments about the studied
populations
Not provided
Health status
Not provided
Study type
Not provided
Enrollment
Not provided
Allocation
Not provided
Intervention model
Not provided
Intervention
model description
Not provided
Masking
Not provided
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-012
Identifier
NCT04246177
Link
https://clinicaltrials.gov/study/NCT04246177
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
Purpose
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular C
Interventions
Intervention 1
Lenvatinib
Intervention 2
Pembrolizumab
Intervention 3
Oral Placebo
Intervention 4
IV Placebo
Intervention 5
TACE
Countries
United States of America
Australia
Brazil
Chile
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-05-22
Anticipated Date of Last Follow-up
2024-11-14
Estimated Primary Completion Date
2028-06-30
Estimated Completion Date
2029-12-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a diagnosis of HCC confirmed by radiology, histology, or cytology
* Has HCC localized to the liver and not amenable to curative treatment
* Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at least 1 month prior to starting study intervention
* Participants with Hepatitis B virus (HBV) are eligible
* Has adequately controlled blood pressure with or without antihypertensive medications
* Has adequate organ function
Exclusion Criteria:
* Is currently a candidate for liver transplantation
* Has had gastric bleeding within the last 6 months
* Has ascites that is not controlled with medication
* Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure
* Has a
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
450
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-992
Identifier
NCT04241185
Link
https://clinicaltrials.gov/study/NCT04241185
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.
MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments.
Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors).
Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer.
A placebo looks like the study medicine but has no stud
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Conventional Radiotherapy (Bladder only)
Intervention 3
Conventional Radiotherapy (Bladder and pelvic nodes)
Intervention 4
Hypofractionated Radiotherapy (Bladder only)
Intervention 5
Cisplatin
Countries
United States of America
Australia
Chile
Czechia
Denmark
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-05-19
Anticipated Date of Last Follow-up
2024-11-22
Estimated Primary Completion Date
2027-01-31
Estimated Completion Date
2031-11-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
* Has clinically nonmetastatic bladder cancer (N0M0)
* Has planned and is eligible to receive chemoradiotherapy (CRT) and one of the protocol-specified radiosensitizing chemotherapy regimens
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Demonstrates adequate organ function
* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of CRT treatment:
* Refrain from donating sperm
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
520
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-A18
Identifier
NCT04221945
Link
https://clinicaltrials.gov/study/NCT04221945
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.
Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.
Purpose
Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo for pembrolizumab
Intervention 3
Cisplatin
Intervention 4
External Beam Radiotherapy (EBRT)
Intervention 5
Brachytherapy
Countries
United States of America
Australia
Austria
Belgium
Brazil
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-05-12
Anticipated Date of Last Follow-up
2025-01-21
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-01-17
Actual Primary Completion Date
2025-01-07
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or FIGO 2014 Stages III-IVA
* Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
* Female participants must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy and agrees not to donate eggs (ova, oo
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1060
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-975
Identifier
NCT04210115
Link
https://clinicaltrials.gov/study/NCT04210115
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in:
* participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
* participants whose tumors express PD-L1 CPS ≥1
* all participants
The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:
* EFS in participants whose tumors express PD-L1 CPS ≥10
* EFS in participants whose tumors express PD-L1 CPS ≥1
* EFS in all participants
* OS in participants whose tumors express PD-L1 CPS ≥10
* OS in participants whose tumors express PD-L1 CPS ≥1
* OS in all p
Purpose
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
Interventions
Intervention 1
pembrolizumab
Intervention 2
placebo
Intervention 3
cisplatin
Intervention 4
5-FU
Intervention 5
radiotherapy
Countries
United States of America
Argentina
Belgium
Brazil
Canada
United Kingdom
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-02-28
Anticipated Date of Last Follow-up
2024-11-13
Estimated Primary Completion Date
2027-02-01
Estimated Completion Date
2027-02-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
* Is deemed suitable for dCRT
* Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.
* Is not expected to require tumor resection during the course of the study
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment
* Has adequate organ function
* Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive metho
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
703
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-991
Identifier
NCT04191096
Link
https://clinicaltrials.gov/study/NCT04191096
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Pro
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Enzalutamide
Intervention 3
Androgen Deprivation Therapy (ADT)
Intervention 4
Placebo
Countries
United States of America
Australia
Austria
Brazil
Canada
Chile
China
Finland
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-02-12
Anticipated Date of Last Follow-up
2025-01-31
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-03
Actual Primary Completion Date
2022-10-31
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has metastatic disease assessed by investigator and verified by BICR by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Willing to maintain continuous Androgen Deprivation Therapy (ADT) with a luteinizing-hormone releasing hormone (LHRH) agonists or antagonists during study treatment or have a history of bilateral orchiectomy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1251
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
EV-302
Identifier
NCT04223856
Link
https://clinicaltrials.gov/study/NCT04223856
Phase
Phase III
Status
Not provided
Sponsor
Astellas Pharma Global Development, Inc.
More details
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Purpose
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Interventions
Not provided
Countries
United States of America
Argentina
China
United Kingdom
Belgium
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-03-30
Anticipated Date of Last Follow-up
2024-09-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2027-11-30
Actual Primary Completion Date
2023-08-08
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
* Measurable disease by investigator assessment according to RECIST v1.1
* Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
* Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:
* Participants that received neoadjuvant chemotherapy with recurrence \>12 months from completion of therapy are permitted
* Participants that received adjuvant chemotherapy following cystectomy with recurrence \>12 months from completion
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
886
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-009
Identifier
NCT04191135
Link
https://clinicaltrials.gov/study/NCT04191135
Phase
Phase II
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:
1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS).
2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS).
As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor r
Purpose
Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Olaparib
Intervention 3
Carboplatin
Intervention 4
Gemcitabine
Countries
United States of America
Canada
Chile
Japan
Poland
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-12-19
Anticipated Date of Last Follow-up
2024-11-11
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-11-18
Actual Primary Completion Date
2022-12-15
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
Induction Period:
* Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy
* Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
* Has measurable disease based on RECIST 1.1
* Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
* Has an Eastern Cooperati
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
462
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
INDUCE-3
Identifier
NCT04128696
Link
https://clinicaltrials.gov/study/NCT04128696
Phase
Phase III
Status
Terminated
Sponsor
GlaxoSmithKline
More details
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) \>=1 R/M HNSCC.
Purpose
Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
Intervention 1
feladilimab
Intervention 2
Pembrolizumab
Intervention 3
Placebo
Countries
United States of America
Argentina
Australia
China
Romania
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-11-21
Anticipated Date of Last Follow-up
2024-06-18
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-04-27
Actual Completion Date
2023-06-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Capable of giving signed informed consent
* Male or female, age \>=18 years
* Histological or cytological documentation of Head and Neck Squamous Cell Carcinoma (HNSCC) that is considered incurable by local therapies
* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx
* No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of multimodal treatment for locally advanced disease)
* Measurable disease per RECIST version 1.1 guidelines
* ECOG Performance PS score of 0 or 1
* Adequate organ function
* Life expectancy of at least 12 weeks
* Female participants: must not be pregnant, not breastfeeding, and at least one of the following conditions apply:
1. Not a woman of childbear
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
315
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYNOTE-966
Identifier
NCT04003636
Link
https://clinicaltrials.gov/study/NCT04003636
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
Purpose
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Gemcitabine
Intervention 3
Cisplatin
Intervention 4
Placebo
Countries
United States of America
Argentina
Australia
China
United Kingdom
Belgium
Brazil
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-09-24
Anticipated Date of Last Follow-up
2025-04-16
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-12-15
Actual Completion Date
2025-04-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function
Exclusion Criteria
* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1069
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-006
Identifier
NCT03976323
Link
https://clinicaltrials.gov/study/NCT03976323
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus (vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Purpose
Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Pemetrexed
Intervention 3
Carboplatin
Intervention 4
Cisplatin
Intervention 5
Olaparib
Countries
United States of America
Canada
Colombia
France
Japan
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-28
Anticipated Date of Last Follow-up
2025-02-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2024-02-07
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
2. Have stage IV nonsquamous NSCLC.
3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
4. Have measurable disease based on RECIST 1.1.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1003
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-008
Identifier
NCT03976362
Link
https://clinicaltrials.gov/study/NCT03976362
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Purpose
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Nab-paclitaxel
Intervention 5
Olaparib
Countries
United States of America
Argentina
Austria
Korea, Republic of
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-28
Anticipated Date of Last Follow-up
2025-01-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2023-09-21
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
2. Have Stage IV squamous NSCLC.
3. Have measurable disease based on RECIST 1.1.
4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Perf
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
851
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-008
Identifier
NCT03976362
Link
https://clinicaltrials.gov/study/NCT03976362
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Purpose
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Nab-paclitaxel
Intervention 5
Olaparib
Countries
United States of America
Argentina
Australia
Austria
Brazil
Germany
Korea, Republic of
Mexico
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-28
Anticipated Date of Last Follow-up
2025-01-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2023-09-21
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
2. Have Stage IV squamous NSCLC.
3. Have measurable disease based on RECIST 1.1.
4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Perf
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
851
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-181 China Extension
Identifier
NCT03933449
Link
https://clinicaltrials.gov/study/NCT03933449
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan.
The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.
Purpose
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-
Interventions
Intervention 1
pembrolizumab
Intervention 2
paclitaxel
Intervention 3
docetaxel
Intervention 4
irinotecan
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-12-29
Anticipated Date of Last Follow-up
2023-03-28
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-02-13
Actual Completion Date
2022-03-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ
* Metastatic disease or locally advanced, unresectable disease
* Life expectancy of greater than 3 months
* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy
* Can provide either a newly obtained or archival tumor tissue sample for intra-tumoral immune-related testing and for anti-programmed cell death (PD)-1
* Participants of reproductive potential must be will
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
123
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYNOTE-866
Identifier
NCT03924856
Link
https://clinicaltrials.gov/study/NCT03924856
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
Purpose
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Gemcitabine
Intervention 3
Cisplatin
Intervention 4
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Intervention 5
Placebo
Countries
United States of America
Australia
Denmark
Israel
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-13
Anticipated Date of Last Follow-up
2025-03-20
Estimated Primary Completion Date
2025-09-02
Estimated Completion Date
2026-09-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology.
* Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) of the chest/abdomen/pelvis.
* Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND).
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
Exclusion Criteria:
* Has a known additional malignancy that is progressing or has required active a
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
907
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-867
Identifier
NCT03924869
Link
https://clinicaltrials.gov/study/NCT03924869
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).
The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
As of protocol amendment 8, the study was stopped due to an interim analysis that did not support the study primary and key secondary endpoints.
Purpose
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNO
Interventions
Intervention 1
Stereotactic Body Radiotherapy (SBRT)
Intervention 2
Pembrolizumab
Intervention 3
Placebo
Countries
United States of America
Argentina
Australia
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-25
Anticipated Date of Last Follow-up
2025-01-29
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-06-11
Actual Completion Date
2025-01-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, \>2 nodules or 2 nodules that cannot be treated in one field (\>2 cm apart and/or total planned target volume \[PTV\] \>163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
* Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
448
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-905
Identifier
NCT03924895
Link
https://clinicaltrials.gov/study/NCT03924895
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.
With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.
With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.
Purpose
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Dec
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND])
Intervention 3
Enfortumab Vedotin
Countries
United States of America
Argentina
Australia
Belgium
Canada
Colombia
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-07-24
Anticipated Date of Last Follow-up
2025-01-27
Estimated Primary Completion Date
2027-05-31
Estimated Completion Date
2027-12-15
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer \[MIBC\] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).
* Clinically nonmetastatic bladder cancer determined by imaging
* Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)
* Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria OR be eligible for treatment with cisplatin but decline treatment with cisplatin-based chemotherapy:
* Impaired renal function with measured or calculat
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
595
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-011
Identifier
NCT03898180
Link
https://clinicaltrials.gov/study/NCT03898180
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC).
The primary hypotheses for this study are that:
1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and
2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with res
Purpose
Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Partici
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Placebo for lenvatinib
Countries
United States of America
Argentina
Australia
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-06
Anticipated Date of Last Follow-up
2025-02-03
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-07-26
Actual Completion Date
2024-05-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma (UC) of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.
* Has ≥1 measurable target lesion per RECIST 1.1 as assessed by the local site investigator/radiologist.
* Has provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated and adequate for Programmed Death-Ligand 1 (PD-L1) evaluation.
* Has received no prior systemic chemotherapy for advanced or metastatic UC with the following exceptions:
* Neoadjuvant (prior to surgery) platinum-based chemotherapy for treatment of muscle-invasive bladder cancer with recurrence \>12 months from completion of the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
505
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
LEAP-001
Identifier
NCT03884101
Link
https://clinicaltrials.gov/study/NCT03884101
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).
As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combinati
Purpose
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
Interventions
Intervention 1
Lenvatinib
Intervention 2
Pembrolizumab
Intervention 3
Paclitaxel
Intervention 4
Carboplatin
Countries
United States of America
Argentina
Australia
Belgium
Canada
China
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-04-11
Anticipated Date of Last Follow-up
2025-02-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-02
Actual Completion Date
2025-02-05
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or nonmeasurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued ≥1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determinati
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
842
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-590 China Extension
Identifier
NCT03881111
Link
https://clinicaltrials.gov/study/NCT03881111
Phase
Phase III
Status
Withdrawn
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this Chinese extension study is to evaluate efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as first-line treatment in a Chinese cohort of participants with locally advanced or metastatic esophageal carcinoma.
The primary efficacy hypotheses are that both progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded independent central review, and overall survival (OS) are superior with pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in all Chinese participants as well as Chinese participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.
Purpose
First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)-China Extension Study
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
5-FU
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-01-21
Anticipated Date of Last Follow-up
2020-02-07
Estimated Primary Completion Date
2021-05-11
Estimated Completion Date
2022-05-11
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ)
* Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment
* Eastern Cooperative Group (ECOG) performance status of 0 to 1
* Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm w
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
Not provided
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-407 China Extension
Identifier
NCT03875092
Link
https://clinicaltrials.gov/study/NCT03875092
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this China extension study, carboplatin and paclitaxel with or without pembrolizumab (MK-3475, KEYTRUDA®) will be administered to Chinese adults with first line metastatic squamous non-small cell lung cancer (NSCLC).
The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS) in Chinese participants.
After analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.
Purpose
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Paclitaxel
Intervention 3
Carboplatin
Intervention 4
Saline placebo for pembrolizumab
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-04-21
Anticipated Date of Last Follow-up
2024-09-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-09-30
Actual Completion Date
2023-09-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer \[AJCC\]) squamous NSCLC.
* Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
* Has not received prior systemic treatment for metastatic NSCLC.
* Has provided tumor tissue from locations not radiated prior to biopsy.
* Has a life expectancy of at least 3 months.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Has adequate organ function.
* If female of childbearing potential, is willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study treatment.
* If male with a femal
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
125
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-937
Identifier
NCT03867084
Link
https://clinicaltrials.gov/study/NCT03867084
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Purpose
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Loc
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Countries
United States of America
Argentina
Australia
China
Belgium
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-28
Anticipated Date of Last Follow-up
2024-11-12
Estimated Primary Completion Date
2027-10-31
Estimated Completion Date
2029-08-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
* Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.
* Has no radiologic evidence of disease prior to enrollment.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
* Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.
* Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
950
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-008
Identifier
NCT03976375
Link
https://clinicaltrials.gov/study/NCT03976375
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Plati
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Docetaxel
Countries
United States of America
Argentina
Australia
Belgium
China
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-26
Anticipated Date of Last Follow-up
2025-02-18
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-08-11
Actual Completion Date
2024-08-22
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous Non-Small Cell Lung Cancer (NSCLC) -Stage IV: M1a, M1b, M1c.
* Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
* Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
* Has PD during/after platinum doublet chemotherapy for metastatic disease.
* Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L85
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
422
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-010
Identifier
NCT04199104
Link
https://clinicaltrials.gov/study/NCT04199104
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.
Hypotheses include:
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
* Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Purpose
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastat
Interventions
Intervention 1
Lenvatinib
Intervention 2
Pembrolizumab
Intervention 3
Placebo
Countries
United States of America
Australia
Brazil
Germany
Korea, Republic of
Peru
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-02-05
Anticipated Date of Last Follow-up
2025-04-16
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-05-30
Actual Completion Date
2025-03-31
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.
Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV.
* Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
* Male participants agree to use approved contracept
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
511
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-042 China Extension
Identifier
NCT03850444
Link
https://clinicaltrials.gov/study/NCT03850444
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In the China extension study, Chinese participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Chinese participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary extension study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy in Chinese participants.
Purpose
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-08-01
Anticipated Date of Last Follow-up
2023-08-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-09-04
Actual Completion Date
2022-09-08
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
* Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSCLC
* PD-L1 positive tumor
* Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Life expectancy of at least 3 months
* No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function
* No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
262
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-921
Identifier
NCT03834506
Link
https://clinicaltrials.gov/study/NCT03834506
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Respons
Purpose
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Docetaxel
Intervention 3
Prednisone
Intervention 4
Placebo
Intervention 5
Dexamethasone
Countries
United States of America
Argentina
Australia
Brazil
United Kingdom
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-02
Anticipated Date of Last Follow-up
2024-09-05
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-06-20
Actual Completion Date
2023-07-18
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progress
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1030
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-641
Identifier
NCT03834493
Link
https://clinicaltrials.gov/study/NCT03834493
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1
Purpose
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Enzalutamide
Intervention 3
Placebo
Countries
United States of America
Argentina
Australia
Austria
Canada
Japan
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-07-28
Anticipated Date of Last Follow-up
2024-11-26
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-05-29
Actual Primary Completion Date
2022-12-12
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) re
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1244
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYLYNK-010
Identifier
NCT03834519
Link
https://clinicaltrials.gov/study/NCT03834519
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.
The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:
1. Overall Survival (OS) and
2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)
As of Amendment 06, the Data Monitoring Committee (DMC
Purpose
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Olaparib
Intervention 3
Abiraterone acetate
Intervention 4
Prednisone
Intervention 5
Enzalutamide
Countries
United States of America
Argentina
Austria
Brazil
Canada
Chile
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-05-02
Anticipated Date of Last Follow-up
2024-12-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-03-14
Actual Completion Date
2024-01-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening
* Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)
* Has received prior treatment with abiraterone acetate OR enzalutamide, but not both
* Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression)
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
793
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-630
Identifier
NCT03833167
Link
https://clinicaltrials.gov/study/NCT03833167
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Purpose
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Interventions
Intervention 1
Pembrolizumab 400 mg
Intervention 2
Placebo
Countries
United States of America
Argentina
Australia
Brazil
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-04-01
Anticipated Date of Last Follow-up
2024-11-27
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-22
Actual Primary Completion Date
2024-06-28
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)
* Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
* Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided
* Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
* Has received an adequate post-op dose of RT (either hypofractio
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
450
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-006
Identifier
NCT03829319
Link
https://clinicaltrials.gov/study/NCT03829319
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.
The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum
Purpose
Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous No
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-03-25
Anticipated Date of Last Follow-up
2025-02-03
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-08-11
Actual Completion Date
2024-08-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer \[AJCC\], version 8 or current version), nonsquamous NSCLC.
* Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
* Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the co
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
761
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-007
Identifier
NCT03829332
Link
https://clinicaltrials.gov/study/NCT03829332
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).
Purpose
Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Placebo for lenvatinib
Countries
United States of America
Australia
Canada
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-03-13
Anticipated Date of Last Follow-up
2025-03-26
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-05-19
Actual Completion Date
2024-04-24
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Has Stage IV NSCLC (American Joint Committee on Cancer \[AJCC 8th edition\])
* Has measurable disease based on RECIST 1.1
* Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score \[TPS\] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory
* Has a life expectancy of ≥3 months
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization
* Male participants must agree to the following during the treatment period and for ≥7 days after the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
623
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-003
Identifier
NCT03820986
Link
https://clinicaltrials.gov/study/NCT03820986
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.
The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per o
Purpose
Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Placebo for lenvatinib
Countries
United States of America
Australia
Austria
China
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-03-12
Anticipated Date of Last Follow-up
2024-11-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-01-18
Actual Completion Date
2024-11-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically or cytologically confirmed melanoma.
* Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy.
* Has been untreated for advanced or metastatic disease except as follows:
1. Proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. Participants that do not have a BRAF V600 mutation but did receive BRAF or BRAF/MEKi therapy are eligible to participate in this study after discussion with the medical monitor.
2. Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], ant
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
674
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-913
Identifier
NCT03783078
Link
https://clinicaltrials.gov/study/NCT03783078
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.
Purpose
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
Interventions
Intervention 1
Pembrolizumab (MK-3475)
Countries
United States of America
Australia
France
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-02-25
Anticipated Date of Last Follow-up
2024-12-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-02-15
Actual Completion Date
2024-02-15
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Be male or female and at least 12 years of age, at the time of signing the informed consent/assent.
* Have histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) as per American Joint Committee on Cancer (AJCC) 8th edition guidelines.
* Have been untreated for advanced or metastatic disease except as follows:
1. Prior intratumoral therapy will be permitted.
2. Prior adjuvant or neoadjuvant therapy containing systemic chemotherapy will be permitted if treatment concluded at least 3 months prior to Cycle 1 Day 1 (C1D1).
3. Prior adjuvant or neoadjuvant therapy containing anti-PD-1/L1 or anti-CTLA-4 (cyt
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
55
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-756
Identifier
NCT03725059
Link
https://clinicaltrials.gov/study/NCT03725059
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS)
Purpose
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Gr
Interventions
Intervention 1
Pembrolizumab (K)
Intervention 2
Placebo (P)
Intervention 3
Paclitaxel (X)
Intervention 4
Doxorubicin (A)
Intervention 5
Epirubicin (E)
Countries
United States of America
Australia
China
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-27
Anticipated Date of Last Follow-up
2024-11-15
Estimated Primary Completion Date
2031-01-24
Estimated Completion Date
2031-01-24
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
* Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
* Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.
Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were ob
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1240
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7902-002
Identifier
NCT03713593
Link
https://clinicaltrials.gov/study/NCT03713593
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.
The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).
Purpose
Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-00
Interventions
Intervention 1
lenvatinib
Intervention 2
pembrolizumab
Intervention 3
saline placebo
Countries
United States of America
Australia
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-31
Anticipated Date of Last Follow-up
2024-09-27
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-06-21
Actual Completion Date
2024-09-24
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Is male or female and ≥18 years of age at the time of signing the informed consent
* Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
* Has a Child-Pugh class A liver score
* Has a predicted life expectancy of \>3 months
* Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1 as confirmed by BICR
* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
* Participants with hepatitis B will be eligible as long as their virus is well controlled
Exclusion Criteria
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
794
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-676
Identifier
NCT03711032
Link
https://clinicaltrials.gov/study/NCT03711032
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.
The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
BCG
Countries
United States of America
Australia
Austria
Colombia
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-24
Anticipated Date of Last Follow-up
2024-12-10
Estimated Primary Completion Date
2025-12-31
Estimated Completion Date
2034-11-20
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladder
* Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease
* Has provided tissue for biomarker analysis
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Has adequate organ function
* During the treatment period and for ≥7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermic
* Female participants who are not pregnant, not breast
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1397
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-859
Identifier
NCT03675737
Link
https://clinicaltrials.gov/study/NCT03675737
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil \[FP regimen\] or oxaliplatin combined with capecitabine \[CAPOX regimen\]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.
The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).
Purpose
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Cisplatin
Intervention 3
5-fluorouracil
Intervention 4
oxaliplatin
Intervention 5
capecitabine
Countries
United States of America
Argentina
Austria
Australia
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-11-08
Anticipated Date of Last Follow-up
2025-03-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-10-03
Actual Completion Date
2025-03-03
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status
* Has human epidermal growth factor receptor 2 (HER2) negative cancer
* Male participants must agree to use contraception during the treatment period and through 95 days after the last dose of chemotherapy, refrain from donating sperm, and be abstinent from heterosexual intercourse, as their preferred and usual lifestyle, and agree to remain abstinent or must agree to use contraception per study protocol unless confirmed to be azoospermic during this period
* Female participants who are not pregnant, not breastfeeding, and at least one of the
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1579
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-826
Identifier
NCT03635567
Link
https://clinicaltrials.gov/study/NCT03635567
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).
Purpose
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Paclitaxel
Intervention 3
Cisplatin
Intervention 4
Carboplatin
Intervention 5
Bevacizumab
Countries
United States of America
Argentina
Australia
Chile
Peru
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-10-25
Anticipated Date of Last Follow-up
2024-06-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-10-03
Actual Completion Date
2024-06-04
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are eligible.
* Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
617
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-811
Identifier
NCT03615326
Link
https://clinicaltrials.gov/study/NCT03615326
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).
Purpose
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KE
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
5-FU
Intervention 5
Oxaliplatin
Countries
United States of America
Australia
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-10-05
Anticipated Date of Last Follow-up
2025-03-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-09-17
Actual Primary Completion Date
2024-03-20
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
* Histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
* HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor
* Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the site investigator
* Male participants must agree to use approved contraception
* Female participants who are not pregnan
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
738
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-716
Identifier
NCT03553836
Link
https://clinicaltrials.gov/study/NCT03553836
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (2
Purpose
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Countries
United States of America
Australia
South Africa
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-09-12
Anticipated Date of Last Follow-up
2024-11-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2033-10-12
Actual Primary Completion Date
2021-06-21
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion:
* Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
* Has not been previously treated for melanoma beyond complete surgical resection
* Has ≤12 weeks between final surgical resection and randomization
* Has no evidence of metastatic disease on imaging as determined by investigator
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants \>16 and \<18 years old
* Has recovered adequately from toxicity and/or complications from surgery prior to study s
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
976
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-716
Identifier
NCT03553836
Link
https://clinicaltrials.gov/study/NCT03553836
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (2
Purpose
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Countries
United States of America
Australia
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-09-12
Anticipated Date of Last Follow-up
2024-11-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2033-10-12
Actual Primary Completion Date
2021-06-21
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion:
* Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
* Has not been previously treated for melanoma beyond complete surgical resection
* Has ≤12 weeks between final surgical resection and randomization
* Has no evidence of metastatic disease on imaging as determined by investigator
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants \>16 and \<18 years old
* Has recovered adequately from toxicity and/or complications from surgery prior to study s
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
976
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
E7080-G000-309
Identifier
NCT03517449
Link
https://clinicaltrials.gov/study/NCT03517449
Phase
Phase III
Status
Not provided
Sponsor
Eisai Inc.
More details
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.
Purpose
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Lenvatinib
Intervention 3
Paclitaxel
Intervention 4
Doxorubicin
Countries
United States of America
Argentina
Australia
Israel
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-06-11
Anticipated Date of Last Follow-up
2025-01-20
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-02-24
Actual Primary Completion Date
2020-10-26
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Has a histologically confirmed diagnosis of endometrial carcinoma (EC)
2. Documented evidence of advanced, recurrent or metastatic EC.
3. Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting.
Note: There is no restriction regarding prior hormonal therapy.
4. Has historical or fresh tumor biopsy specimen for determination of mismatch repair (MMR) status.
5. Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR.
6. Has Eastern Cooperative Oncology
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
827
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-789
Identifier
NCT03515837
Link
https://clinicaltrials.gov/study/NCT03515837
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib \[TAGRISSO®\] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy i
Purpose
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastati
Interventions
Intervention 1
pembrolizumab
Intervention 2
pemetrexed
Intervention 3
carboplatin
Intervention 4
cisplatin
Intervention 5
saline solution
Countries
United States of America
Argentina
Australia
Brazil
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-06-29
Anticipated Date of Last Follow-up
2024-11-05
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-01-17
Actual Completion Date
2023-10-02
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of Stage IV non-squamous NSCLC.
* Documentation of tumor activating EGFR mutation, specifically either DEL19 or L858R.
* Investigator-determined radiographic disease progression per RECIST 1.1 after treatment with an EGFR TKI therapy: a) Participants previously treated with 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation; b) Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR TKI (e.g. erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment; c) Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless o
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
492
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-587
Identifier
NCT03486873
Link
https://clinicaltrials.gov/study/NCT03486873
Phase
Phase III
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with
Purpose
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Standard of Care (SOC)
Intervention 3
Lenvatinib
Intervention 4
Olaparib
Intervention 5
MK-4280
Countries
United States of America
Australia
Russian Federation
Romania
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-21
Anticipated Date of Last Follow-up
2025-05-02
Estimated Primary Completion Date
2043-08-04
Estimated Completion Date
2043-08-04
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrates adequate organ function.
* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except al
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
3500
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-671
Identifier
NCT03425643
Link
https://clinicaltrials.gov/study/NCT03425643
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
Purpose
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-smal
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
Gemcitabine
Intervention 5
Pemetrexed
Countries
United States of America
Argentina
Australia
Belgium
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-04-24
Anticipated Date of Last Follow-up
2024-11-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-06-29
Actual Primary Completion Date
2023-07-10
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
* If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
* If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own u
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
797
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-689
Identifier
NCT03765918
Link
https://clinicaltrials.gov/study/NCT03765918
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Purpose
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Interventions
Intervention 1
Pembrolizumab 200 mg
Intervention 2
Radiotherapy 60 Gray
Intervention 3
Radiotherapy 66 Gray
Intervention 4
Radiotherapy 70 Gray
Intervention 5
Cisplatin 100 mg/m^2
Countries
United States of America
Argentina
Australia
Brazil
Colombia
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-17
Anticipated Date of Last Follow-up
2025-02-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-09-10
Actual Primary Completion Date
2024-07-25
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
714
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-001
Identifier
NCT03740165
Link
https://clinicaltrials.gov/study/NCT03740165
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.
The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxe
Purpose
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo for pembrolizumab
Intervention 3
Carboplatin
Intervention 4
Paclitaxel
Intervention 5
Olaparib
Countries
United States of America
Australia
Belgium
Israel
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-18
Anticipated Date of Last Follow-up
2024-11-15
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-05-29
Actual Primary Completion Date
2024-08-26
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
* Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
* Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
* Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
* Is able to
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1367
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
7339-001
Identifier
NCT03740165
Link
https://clinicaltrials.gov/study/NCT03740165
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.
The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxe
Purpose
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo for pembrolizumab
Intervention 3
Carboplatin
Intervention 4
Paclitaxel
Intervention 5
Olaparib
Countries
United States of America
Australia
Brazil
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-12-18
Anticipated Date of Last Follow-up
2024-11-15
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-05-29
Actual Primary Completion Date
2024-08-26
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
* Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
* Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
* Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
* Is able to
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1367
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-598
Identifier
NCT03302234
Link
https://clinicaltrials.gov/study/NCT03302234
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.
With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembro
Purpose
Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Ipilimumab
Intervention 3
Placebo
Countries
United States of America
Argentina
Australia
Brazil
South Africa
Ukraine
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-12-14
Anticipated Date of Last Follow-up
2023-09-25
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-09-01
Actual Completion Date
2022-09-07
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer version 8)
* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by investigator
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has a life expectancy of at least 3 months
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
* Female participants of reproductive potential must agree to use contrace
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
568
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-585
Identifier
NCT03221426
Link
https://clinicaltrials.gov/study/NCT03221426
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
* Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
* Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
With Amen
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
Capecitabine
Intervention 5
5-fluorouracil
Countries
United States of America
Belgium
Brazil
China
Israel
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-10-09
Anticipated Date of Last Follow-up
2025-01-28
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-04-23
Actual Primary Completion Date
2024-02-16
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
* Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
* Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
* Fe
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1007
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-585
Identifier
NCT03221426
Link
https://clinicaltrials.gov/study/NCT03221426
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
* Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
* Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
With Amen
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
Capecitabine
Intervention 5
5-fluorouracil
Countries
United States of America
Belgium
Brazil
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-10-09
Anticipated Date of Last Follow-up
2025-01-28
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-04-23
Actual Primary Completion Date
2024-02-16
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
* Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
* Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
* Fe
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1007
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-590
Identifier
NCT03189719
Link
https://clinicaltrials.gov/study/NCT03189719
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.
The overall primary efficacy hypotheses are as follows:
1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score \[CPS\] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
2. In participants wit
Purpose
First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
5-FU
Countries
United States of America
Argentina
Australia
Brazil
China
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-07-25
Anticipated Date of Last Follow-up
2024-10-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-07-02
Actual Completion Date
2023-07-10
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ)
* Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment
* Eastern Cooperative Group (ECOG) performance status of 0 to 1
* Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm w
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
749
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-564
Identifier
NCT03142334
Link
https://clinicaltrials.gov/study/NCT03142334
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.
The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.
Purpose
Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Countries
United States of America
Australia
Brazil
Canada
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-06-09
Anticipated Date of Last Follow-up
2024-11-08
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-28
Actual Primary Completion Date
2020-12-14
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
* Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment
* Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment
* Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, A
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
994
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYNOTE-698/ECHO-303
Identifier
NCT03374488
Link
https://clinicaltrials.gov/study/NCT03374488
Phase
Phase III
Status
Completed
Sponsor
Incyte Corporation
More details
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.
Purpose
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Epacadostat
Intervention 3
Placebo
Countries
United States of America
Australia
Canada
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-12-22
Anticipated Date of Last Follow-up
2021-11-02
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-07-27
Actual Completion Date
2020-07-23
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
* Progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. A participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy.
* Measurable disease based on RECIST v1.1.
* Have provided an archival tumor tissue sample or newly obtained
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
84
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-604
Identifier
NCT03066778
Link
https://clinicaltrials.gov/study/NCT03066778
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.
The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
With protocol Amendment 07 (03-Oct-2018), the outcome measure of
Purpose
A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Normal saline solution
Intervention 3
Carboplatin
Intervention 4
Cisplatin
Intervention 5
Etoposide
Countries
United States of America
Australia
Canada
Russian Federation
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-05-02
Anticipated Date of Last Follow-up
2022-09-02
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-12-02
Actual Completion Date
2021-09-21
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
* Has extensive-stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer (AJCC), Seventh Edition
* Has ≥1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has Eastern Co
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
453
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-394
Identifier
NCT03062358
Link
https://clinicaltrials.gov/study/NCT03062358
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo given with best supportive care (BSC) in Asian participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that overall survival is prolonged in participants who receive pembrolizumab compared to those who receive placebo.
Purpose
Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)
Interventions
Intervention 1
pembrolizumab
Intervention 2
placebo
Intervention 3
best supportive care (BSC)
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-04-27
Anticipated Date of Last Follow-up
2024-10-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-06-30
Actual Completion Date
2024-10-15
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)
* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach.
* Has a Child-Pugh A liver score within 7 days prior to first dose of study medication
* Has a life expectancy of \>3 months
* Has at least one measurable lesion based on RECIST version 1.1 as determined by investigator.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 7 days prior to receiving the first dose of study medication.
* Has documented objective radiograph
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
453
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-412
Identifier
NCT03040999
Link
https://clinicaltrials.gov/study/NCT03040999
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Purpose
Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Placebo
Intervention 3
Cisplatin
Intervention 4
Accelerated Fractionation (AFX) Radiotherapy
Intervention 5
Standard Fractionation (SFX) Radiotherapy
Countries
United States of America
Australia
Brazil
Netherlands
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-04-05
Anticipated Date of Last Follow-up
2024-08-28
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-05-31
Actual Completion Date
2024-08-21
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
* Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and ne
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
804
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-522
Identifier
NCT03036488
Link
https://clinicaltrials.gov/study/NCT03036488
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Fol
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Canc
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Carboplatin
Intervention 3
Paclitaxel
Intervention 4
Doxorubicin
Intervention 5
Epirubicin
Countries
United States of America
Australia
Brazil
Canada
Israel
Russian Federation
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-03-07
Anticipated Date of Last Follow-up
2025-01-08
Estimated Primary Completion Date
2025-09-30
Estimated Completion Date
2025-09-30
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:
* T1c, N1-N2
* T2, N0-N2
* T3, N0-N2
* T4a-d, N0-N2
* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performa
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1174
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
KEYNOTE-672/ECHO-307
Identifier
NCT03361865
Link
https://clinicaltrials.gov/study/NCT03361865
Phase
Phase III
Status
Completed
Sponsor
Incyte Corporation
More details
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
Purpose
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Epacadostat
Intervention 3
Placebo
Countries
United States of America
Australia
Belgium
Canada
France
Korea, Republic of
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-12-04
Anticipated Date of Last Follow-up
2021-11-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-08-09
Actual Completion Date
2020-08-04
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
* Measurable disease based on RECIST v1.1.
* Be considered ineligible to receive cisplatin-based combination therapy, based on protocol-defined criteria.
* Have provided tissue for PD-L1 analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
* Have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 within 14 days prior to randomization.
* Adequate organ function per protocol-defined criteri
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
93
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
KEYNOTE-679/ECHO-302
Identifier
NCT03260894
Link
https://clinicaltrials.gov/study/NCT03260894
Phase
Phase III
Status
Not provided
Sponsor
Incyte Corporation
More details
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.
Purpose
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Epacadostat
Intervention 3
Sunitinib
Intervention 4
Pazopanib
Countries
United States of America
Australia
Brazil
Canada
New Zealand
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-12-07
Anticipated Date of Last Follow-up
2025-03-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-06-30
Actual Primary Completion Date
2018-08-22
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
* Must not have received any prior systemic therapy for their mRCC.
* Measurable disease based on RECIST v1.1.
* Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
* Karnofsky performance status ≥ 70%.
* Adequate organ function per protocol-defined criteria.
Exclusion Criteria:
* Use of protocol-defined prior/concomitant therapy.
* Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
* History of severe hypersensitivity reaction to study treatments or thei
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
129
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-063
Identifier
NCT03019588
Link
https://clinicaltrials.gov/study/NCT03019588
Phase
Phase III
Status
Terminated
Sponsor
Merck Sharp & Dohme LLC
More details
The study will compare the efficacy and safety of treatment with pembrolizumab (MK-3475) versus paclitaxel in Asian, programmed death-ligand 1 (PD-L1) positive participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.
The primary study hypotheses are that pembrolizumab prolongs Overall Survival (OS) compared to paclitaxel and that pembrolizumab prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by blinded central radiologists' review compared to paclitaxel.
Purpose
Efficacy and Safety Study of Pembrolizumab (MK-3475) Versus Paclitaxel in Asian Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-line Therapy W
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Paclitaxel
Countries
China
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-02-16
Anticipated Date of Last Follow-up
2022-06-21
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-06-29
Actual Completion Date
2021-06-29
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically or cytologically-confirmed diagnosis of gastric or GEJ adenocarcinoma.
* Has metastatic disease or locally advanced, unresectable disease.
* Has measurable disease as defined by RECIST 1.1 as determined by investigator.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment.
* Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/fluoropyrimidine doublet.
* Is willing to provide tissue for PD-L1 biomarker analysis.
* Has PD-L1 positive tumor (based on analysis of sample provided to core lab).
* Female participants of childbearing potential must be willing to
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
94
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
PROMISE-meso
Identifier
NCT02991482
Link
https://clinicaltrials.gov/study/NCT02991482
Phase
Phase III
Status
Completed
Sponsor
ETOP IBCSG Partners Foundation
More details
Trial comparing standard treatment (chemotherapy) with pembrolizumab treatment in patients with advanced pretreated malignant mesothelioma.
Purpose
PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma
Interventions
Intervention 1
Pembrolizumab
Intervention 2
Gemcitabine
Intervention 3
Vinorelbine
Countries
Spain
Switzerland
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-09-12
Anticipated Date of Last Follow-up
2022-08-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-02-20
Actual Completion Date
2021-11-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically confirmed malignant pleural mesothelioma (all subtypes are eligible)
* Progressing after or on previous platinum based chemotherapy.
* Availability of tumour tissue for translational research.
* Female and male patients aged 18 years or over.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Life expectancy of at least 3 months.
* Measurable or evaluable disease according to RECIST 1.1 criteria.
* Adequate renal function
* Creatinine 1.5 × Upper Limit of Normal (ULN) OR Calculated creatinine clearance 40 mL/min (using the Cockroft-Gault formula).
* Adequate haematological function
* Haemoglobin 90 g/L or 5.6 mmol/L
* White Blood Cell (WBC) 1.0 × 109/L
* Lymphocytes 0.5 g/L
* Absolute neutrophils count (ANC) 1.5 × 109/L
* Platelet co
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
144
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-033
Identifier
NCT02864394
Link
https://clinicaltrials.gov/study/NCT02864394
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypotheses of this study are that pembrolizumab (MK-3475) prolongs overall survival (OS) and that pembrolizumab prolongs progression-free survival (PFS), compared to docetaxel in participants with PD-L1 positive tumors.
Purpose
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-09-07
Anticipated Date of Last Follow-up
2024-08-30
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-09-09
Actual Completion Date
2022-10-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Chinese participants must be born, raised, and reside in China
* Has a histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent NSCLC and have at least one measurable lesion as defined by RECIST 1.1
* Has a life expectancy of ≥3 months
* Has progression of disease (investigator determined) per RECIST 1.1 after treatment with at least two cycles of a platinum-containing doublet
* Has documentation of epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) translocation status
* Participants with an EGFR sensitizing mutation tumor will be excluded
* Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 10 days prior to study start
* Has provided archival tumor tissue sample or newly obta
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
425
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-361
Identifier
NCT02853305
Link
https://clinicaltrials.gov/study/NCT02853305
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to determine the efficacy and safety of pembrolizumab (pembro, MK-3475) with or without chemotherapy versus chemotherapy alone in participants with advanced or metastatic urothelial carcinoma (bladder cancer).
The primary hypotheses are that pembrolizumab plus chemotherapy is superior to chemotherapy alone with respect to Progression-free Survival (PFS) and Overall Survival (OS) in all participants, and that pembrolizumab alone is superior to chemotherapy alone with respect to OS in all participants and in participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥10%).
Purpose
Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-09-15
Anticipated Date of Last Follow-up
2023-08-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-04-29
Actual Completion Date
2022-09-15
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter \[upper urinary tract\], bladder, or urethra. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
* Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
* Has received no prior systemic chemotherapy for advanced or metastatic urothelial carcinoma, with the following exceptions:
* Neoadjuvant platinum-based chemotherapy with recurrence \>12 months from completion of therapy is permitted.
* Adjuvant platinum-based chemotherapy following radical
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1010
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-426
Identifier
NCT02853331
Link
https://clinicaltrials.gov/study/NCT02853331
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC).
The primary hypotheses of this study are:
1. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
2. The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).
Purpose
Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-09-16
Anticipated Date of Last Follow-up
2024-11-15
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2018-10-18
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features
* Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease
* Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist
* Has received no prior systemic therapy for advanced RCC.
* Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
* Has Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.
* If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 we
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
861
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-355
Identifier
NCT02819518
Link
https://clinicaltrials.gov/study/NCT02819518
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
The study will consist of two parts.
In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy.
In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.
The primary hypotheses are that:
1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in:
* all
Purpose
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-07-27
Anticipated Date of Last Follow-up
2024-11-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-06-15
Actual Completion Date
2023-10-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
* Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
* Has been treated with (neo)adjuvant anthracycline, if they received systemic
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
882
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
CLEAR
Identifier
NCT02811861
Link
https://clinicaltrials.gov/study/NCT02811861
Phase
Phase III
Status
Not provided
Sponsor
Eisai Inc.
More details
The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).
Purpose
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-10-13
Anticipated Date of Last Follow-up
2024-10-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-03-31
Actual Primary Completion Date
2020-08-28
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
1. Histological or cytological confirmation of RCC with a clear-cell component (original tissue diagnosis of RCC is acceptable).
2. Documented evidence of advanced RCC.
3. At least 1 measurable target lesion according to RECIST 1.1 meeting the following criteria:
* Lymph node (LN) lesion that measures at least 1 dimension as greater than or equal to (\>=) 1.5 cm in the short axis
* Lymph node (LN) lesion that measures at least 1 dimension as greater than or equal to (\>=) 1.5 centimeter (cm) in the short axis
* Non-nodal lesion that measures greater than or equal to (\>=) 1.0 cm in the longest diameter
* The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radio
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1069
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
I227
Identifier
NCT02784171
Link
https://clinicaltrials.gov/study/NCT02784171
Phase
Phase II/III
Status
Completed
Sponsor
Canadian Cancer Trials Group
More details
Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show that this drug works by helping improve the body's immune response to help fight cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth and/or spreading of cancer.
Purpose
Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-11-11
Anticipated Date of Last Follow-up
2024-12-05
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-10-11
Actual Completion Date
2024-10-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Patients must have histologically confirmed malignant pleural mesothelioma. Patients must be eligible to receive standard chemotherapy with pemetrexed and cisplatin and have no contraindications to standard chemotherapy.
* Patients must have unresectable advanced and/or metastatic disease, incurable by standard therapies.
* All patients must have a cellular tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses (See Section 11.0) and the centre/pathologist must have agreed to the submission of the specimen(s).
* Presence of radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:
* CT scan (with slice thickness of ≤ 5 mm): ≥
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
520
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-407
Identifier
NCT02775435
Link
https://clinicaltrials.gov/study/NCT02775435
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel) with or without pembrolizumab (MK-3475, KEYTRUDA®) in adults with first line metastatic squamous non-small cell lung cancer (NSCLC).
The primary hypotheses are that treatment with pembrolizumab prolongs: 1) Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor compared to placebo, and 2) Overall Survival (OS).
After analysis of interim results was conducted, the protocol was amended (Amendment 5) to allow participants the option to discontinue placebo in the control arm and to switch to pembrolizumab in the event of documented progressive disease as assessed by central review.
Purpose
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-06-09
Anticipated Date of Last Follow-up
2024-10-07
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-04-03
Actual Completion Date
2023-09-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b-American Joint Committee on Cancer \[AJCC\] 7th edition) squamous NSCLC.
* Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment.
* Has not received prior systemic treatment for metastatic NSCLC.
* Has provided tumor tissue from locations not radiated prior to biopsy.
* Has a life expectancy of at least 3 months.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Has adequate organ function.
* If female of childbearing potential, is willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of study drug.
* If male with
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
559
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-240
Identifier
NCT02702401
Link
https://clinicaltrials.gov/study/NCT02702401
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475) in participants with previously systemically treated advanced hepatocellular carcinoma (HCC).
The primary objectives of this study are to determine 1) Progression-Free Survival (PFS) and 2) Overall Survival (OS) of pembrolizumab plus best supportive care (BSC) compared with placebo plus BSC. The primary hypotheses of this study are: 1) pembrolizumab plus BSC prolongs PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed by Blinded Independent Central Review compared to placebo plus BSC, and 2) pembrolizumab plus BSC improves OS compared with placebo plus BSC.
Effective with Amendment 4: Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
Purpose
Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-05-26
Anticipated Date of Last Follow-up
2022-08-30
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-01-02
Actual Completion Date
2021-09-22
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a HCC diagnosis confirmed by radiology, histology or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach.
* Has a Child-Pugh Class A liver score within 7 days of first dose of study drug.
* Has a predicted life expectancy \>3 months.
* Has at least one measurable lesion based on RECIST 1.1 as confirmed by the blinded central imaging vendor.
* Has a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 7 days of first dose of study drug.
* Has documented objective
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
413
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-204
Identifier
NCT02684292
Link
https://clinicaltrials.gov/study/NCT02684292
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be randomized to receive either pembrolizumab or brentuximab vedotin (BV) for up to 35 three-week cycles of treatment.
The primary hypotheses of this study are that treatment with pembrolizumab prolongs Progression-free Survival (PFS) and Overall Survival (OS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with BV.
Purpose
Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-05-23
Anticipated Date of Last Follow-up
2024-11-08
Estimated Primary Completion Date
2025-07-18
Estimated Completion Date
2025-07-18
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has relapsed (disease progression after most recent therapy) or refractory (failure to achieve Complete Response \[CR\] or Partial Response \[PR\] to most recent therapy) classical Hodgkin Lymphoma.
* Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously treated with BV.
* Has measurable disease defined as ≥1 lesion that can be accurately measured in ≥2 dimensions with spiral computed tomography (CT) scan or combined CT/positron emission tomography (PET) scan. Minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis.
* Is able to provide an evaluable core or excisional lymph node biopsy for biomarker analysis from an archival (\>60 days) or newly obtained (within 60 days) biopsy at Screening (Visit 1).
* Ha
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
304
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-122
Identifier
NCT02611960
Link
https://clinicaltrials.gov/study/NCT02611960
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475) versus standard treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.
The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
With Amendment 7 (effective 2-March-2022), upon study completion, participants will be discontinued and may be enrolled in an extension study.
Purpose
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-04-18
Anticipated Date of Last Follow-up
2023-06-26
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-11-30
Actual Completion Date
2022-09-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically confirmed non-keratinizing differentiated NPC or undifferentiated NPC
* Metastatic disease or incurable locally recurrent disease
* Treatment with prior platinum therapy
* Tumor tissue available for programmed cell death ligand 1 (PD-L1) testing
* Measurable disease based on RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 180 days after the last dose of study drug
* Life expectancy of at least 3 months
Exclusion Criteria:
* Disease is suitable for local therapy administered with curative intent
* Participants previously treate
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
233
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-185
Identifier
NCT02579863
Link
https://clinicaltrials.gov/study/NCT02579863
Phase
Phase III
Status
Terminated
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare the efficacy of lenalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone without pembrolizumab in terms of progression-free survival (PFS) in participants with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (Auto-SCT). The study's primary hypothesis is that pembrolizumab in dexamethasone prolongs progression free survival (PFS) as assessed by Clinical Adjudication Committee (CAC) blinded central review using International Myeloma Working Group (IMWG) response criteria compared to treatment combination with lenalidomide and low-dose with lenalidomide and low-dose dexamethasone (standard of care, SOC) alone.
Purpose
Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-10-19
Anticipated Date of Last Follow-up
2021-06-29
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-07-09
Actual Completion Date
2020-07-13
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Confirmed diagnosis of active multiple myeloma and measurable disease.
* Ineligible to receive treatment with auto-SCT due to age (≥65 years old) or any significant coexisting medical condition (cardiac, renal, pulmonary or hepatic dysfunction), likely to have a negative impact on tolerability of auto-SCT. Participants \<65 years of age who refuse auto-SCT are not eligible for this study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Female participants of childbearing potential must have 2 negative urine pregnancy tests (with a sensitivity of at least 25 Milli-international units/milliliter) within 10 to 14 days and within 24 hours prior to receiving study medication.
* Female participants of childbearing potential must agree to use ade
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
310
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-189
Identifier
NCT02578680
Link
https://clinicaltrials.gov/study/NCT02578680
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).
With Amendment 10 (effective date 23-Dec-2019), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded, and all participants in the 'co
Purpose
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-01-15
Anticipated Date of Last Follow-up
2024-09-05
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-11-08
Actual Completion Date
2023-06-22
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV nonsquamous NSCLC.
* Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
* Has measurable disease.
* Has not received prior systemic treatment for their advanced/metastatic NSCLC.
* Can provide tumor tissue.
* Has a life expectancy of at least 3 months.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
* Has adequate organ function
* If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agent
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
616
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-183
Identifier
NCT02576977
Link
https://clinicaltrials.gov/study/NCT02576977
Phase
Phase III
Status
Terminated
Sponsor
Merck Sharp & Dohme LLC
More details
The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment. The study's 2 primary hypotheses are: 1. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs PFS as assessed by Clinical Adjudication Committee (CAC) blinded central review using International Myeloma Working Group Criteria for Response Assessment in Multiple Myeloma (IMWG) criteria compared to treatment with pomalidomide and low dose dexamethasone standard of care (SOC) alone. 2. Pemb
Purpose
Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-10-19
Anticipated Date of Last Follow-up
2021-09-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-07-09
Actual Completion Date
2020-07-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has a confirmed diagnosis of active multiple myeloma and measurable disease
* Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy and must have failed last line of treatment (refractory to last line of treatment)
* Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND proteasome inhibitor alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor
* Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication
* Female participants of childbea
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
251
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
INCB 24360-301 (ECHO-301)
Identifier
NCT02752074
Link
https://clinicaltrials.gov/study/NCT02752074
Phase
Phase III
Status
Completed
Sponsor
Incyte Corporation
More details
The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma
Purpose
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-06-21
Anticipated Date of Last Follow-up
2020-08-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-01-08
Actual Completion Date
2019-08-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have histologically or cytologically confirmed melanoma
* Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
* A minimum of 1 measurable lesion by CT or MRI
* Provide a baseline tumor biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria:
* Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
* Has received prior adjuvant therapy, monoclonal antibody or an investigational ag
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
706
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
INCB 24360-301 (ECHO-301)
Identifier
NCT02752074
Link
https://clinicaltrials.gov/study/NCT02752074
Phase
Phase III
Status
Completed
Sponsor
Incyte Corporation
More details
The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma
Purpose
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-06-21
Anticipated Date of Last Follow-up
2020-08-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-01-08
Actual Completion Date
2019-08-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Have histologically or cytologically confirmed melanoma
* Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
* A minimum of 1 measurable lesion by CT or MRI
* Provide a baseline tumor biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria:
* Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
* Has received prior adjuvant therapy, monoclonal antibody or an investigational ag
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
706
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-181
Identifier
NCT02564263
Link
https://clinicaltrials.gov/study/NCT02564263
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that had progressed after first-line standard therapy were randomized to receive either pembrolizumab (MK-3475) OR the Investigator's choice of standard chemotherapy with paclitaxel, docetaxel, or irinotecan.
The primary study hypothesis was that treatment with pembrolizumab would prolong overall survival (OS) as compared to treatment with standard chemotherapy.
Purpose
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (M
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-12-01
Anticipated Date of Last Follow-up
2023-02-09
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-10-15
Actual Completion Date
2022-03-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ
* Metastatic disease or locally advanced, unresectable disease
* Life expectancy of greater than 3 months
* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Documented radiographic or clinical disease progression on no more or less than one previous line of standard therapy
* Can provide either a newly obtained or archival tumor tissue sample for intra-tumoral immune-related testing and for anti-programmed cell death (PD)-1
* Participants of reproductive potential must be will
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
628
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-177
Identifier
NCT02563002
Link
https://clinicaltrials.gov/study/NCT02563002
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, participants with stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal carcinoma (CRC) will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
Purpose
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-11-30
Anticipated Date of Last Follow-up
2024-09-18
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-02-19
Actual Completion Date
2023-07-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
* Life expectancy of at least 3 months
* Measurable disease
* Female participants of childbearing potential must be willing to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of standard of care (SOC) therapy or 120 days after the last pembrolizumab dose
* Male participants must agree to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of study medication for chemotherapy arm (no contraception requirement for pembroli
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
307
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-119
Identifier
NCT02555657
Link
https://clinicaltrials.gov/study/NCT02555657
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.
Purpose
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-10-13
Anticipated Date of Last Follow-up
2021-11-09
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-04-11
Actual Completion Date
2020-11-10
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Centrally confirmed Stage IV/M1 mTNBC
* Newly obtained tumor biopsy from metastatic site
* Central determination of programmed cell death ligand 1 (PD-L1) tumor status
* Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
* Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
* Adequate organ function
Exclusion Criteria:
* Participation in another clinical trial within 4 weeks
* Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
* Chemotherapy, targeted small molecule therapy,
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
622
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
PEARLS
Identifier
NCT02504372
Link
https://clinicaltrials.gov/study/NCT02504372
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.
Purpose
Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-11-06
Anticipated Date of Last Follow-up
2024-02-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2027-02-02
Actual Primary Completion Date
2023-01-24
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study
* Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin
* Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function performed within 10 days of treatment initiation
* Female participants of childbearing potential must have a negative uri
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1177
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-062
Identifier
NCT02494583
Link
https://clinicaltrials.gov/study/NCT02494583
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants whose tumors express programmed death-ligand 1 (PD-L1) will be randomly assigned to one of the three treatment arms of the study: pembrolizumab as monotherapy \[pembro mono\], pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine \[pembro combo\], or placebo plus SOC chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine \[SOC\].
The primary study hypotheses are that pembrolizumab in combination with SOC chemotherapy is superior to SOC chemotherapy alone in terms of Progression-free Survival (PFS) and Overall Survival (OS) in participants with PD-L
Purpose
Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-07-31
Anticipated Date of Last Follow-up
2023-03-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-03-26
Actual Completion Date
2022-06-06
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of study medication
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
* Human epidermal growth factor receptor 2- (HER2/neu-) negative and programmed cell death ligand 1 (PD-L1)-positive
* Has measurable disease
* Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
* Male participants of childbearing potential should agree to use an adequate method of contraception star
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
763
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
MASTERKEY232
Identifier
NCT02626000
Link
https://clinicaltrials.gov/study/NCT02626000
Phase
Phase I
Status
Completed
Sponsor
Amgen
More details
The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Purpose
Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-04-06
Anticipated Date of Last Follow-up
2021-08-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-11-02
Actual Completion Date
2020-08-28
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria
* Male or female age ≥ 18 years at the time of informed consent
* Histologically confirmed diagnosis of metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx, or larynx. Disease must be unsuitable for curative surgical resection and must not be amenable to curative radiotherapy.
* Disease must have progressed after treatment with a platinum-containing regimen and should be defined as one of the following:
i. disease progression or recurrence between 3 to 6 months of prior curatively intended multimodal therapy (which includes platinum therapy) for locoregionally advanced SCCHN.
ii. disease progression or recurrence after prior platinum therapy in the recurrent or metastatic setting Note: This criterion is only applicable for subjects who have not
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
36
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-061
Identifier
NCT02370498
Link
https://clinicaltrials.gov/study/NCT02370498
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.
Purpose
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (M
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-05-11
Anticipated Date of Last Follow-up
2022-05-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-10-26
Actual Completion Date
2021-06-10
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Confirmed metastatic or locally advanced, unresectable disease (by computed tomography \[CT\] scan or clinical evidence)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine doublet
* Willing to provide tumor tissue for PD-L1 biomarker analysis (new or archived specimens with agreement of Sponsor). As of 20 March 2016, participants must be PD-L1 positive to be enrolled.
* Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of disease progression on treatment containing t
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
592
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-061
Identifier
NCT02370498
Link
https://clinicaltrials.gov/study/NCT02370498
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.
Purpose
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (M
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-05-11
Anticipated Date of Last Follow-up
2022-05-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-10-26
Actual Completion Date
2021-06-10
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Confirmed metastatic or locally advanced, unresectable disease (by computed tomography \[CT\] scan or clinical evidence)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine doublet
* Willing to provide tumor tissue for PD-L1 biomarker analysis (new or archived specimens with agreement of Sponsor). As of 20 March 2016, participants must be PD-L1 positive to be enrolled.
* Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of disease progression on treatment containing t
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
592
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-042
Identifier
NCT02220894
Link
https://clinicaltrials.gov/study/NCT02220894
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy.
Purpose
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-10-30
Anticipated Date of Last Follow-up
2023-10-06
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-09-04
Actual Completion Date
2022-09-12
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
* Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSCLC
* PD-L1 positive tumor
* Measureable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Life expectancy of at least 3 months
* No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function
* No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1274
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-024
Identifier
NCT02142738
Link
https://clinicaltrials.gov/study/NCT02142738
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study to assess the efficacy and safety of pembrolizumab (MK-3475/SCH 900475) compared to standard of care (SOC) platinum-based chemotherapies in the treatment of participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with pembrolizumab than when treated with SOC platinum-based chemotherapies.
With Amendment 09 (20 December 2017), once participants have achieved the study objective or the study has ended, participants will be discontinued from this study and enrolle
Purpose
Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-08-25
Anticipated Date of Last Follow-up
2022-05-17
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2016-05-09
Actual Completion Date
2021-05-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histological or cytological diagnosis of Stage IV NSCLC lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation, and received no prior systemic chemotherapy treatment for their metastatic NSCLC
* At least one radiographically measurable lesion per RECIST 1.1
* Life expectancy of at least 3 months
* Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
* Adequate organ function
* No history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years si
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
305
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-054
Identifier
NCT02362594
Link
https://clinicaltrials.gov/study/NCT02362594
Phase
Phase III
Status
Not provided
Sponsor
Merck Sharp & Dohme LLC
More details
This study will assess whether post-surgery therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA \[\> 1 mm metastasis\], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death-ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo as post-surgery therapy in Part 1. In Part 2, participants who experience a disease recurrence are eligible for pembrolizumab treatment (if treated with placebo in Part 1) or pembrolizumab rechallenge (if treated with pembrolizumab in Part 1). Partici
Purpose
Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-07-16
Anticipated Date of Last Follow-up
2023-07-31
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2026-07-31
Actual Primary Completion Date
2018-01-08
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
* Completely resected Stage III melanoma
* Tumor tissue available for evaluation of PD-L1 expression
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)
* Female participants of childbearing potential should be willing to use adequate methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
* Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy t
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1019
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-045
Identifier
NCT02256436
Link
https://clinicaltrials.gov/study/NCT02256436
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
Participants with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy will be randomly assigned to receive Investigator's choice of paclitaxel, docetaxel, or vinflunine (Control), or pembrolizumab. The primary study hypotheses are that pembrolizumab will prolong Overall Survival (OS) and Progression-free Survival (PFS) compared to paclitaxel, docetaxel, or vinflunine.
Purpose
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-10-22
Anticipated Date of Last Follow-up
2021-08-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2016-09-07
Actual Completion Date
2020-10-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion criteria:
* Histologically- or cytologically-confirmed diagnosis of urothelial cancer of the renal pelvis, ureter, bladder, or urethra, that is transitional cell or mixed transitional/non-transitional (predominantly transitional) cell type
* Progression or recurrence of urothelial cancer following a first-line platinum-containing regimen (e.g cisplatin, carboplatin) for metastatic or inoperable locally advanced disease; or adjuvant platinum-based therapy following cystectomy for localized muscle-invasive urothelial cancer with recurrence/progression \<=12 months following completion of therapy; or neoadjuvant platinum-containing therapy prior to cystectomy for localized muscle-invasive urothelial cancer with recurrence \<=12 months following completion of therapy
* No more than
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
542
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-040
Identifier
NCT02252042
Link
https://clinicaltrials.gov/study/NCT02252042
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
Purpose
Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-11-17
Anticipated Date of Last Follow-up
2023-06-30
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-05-15
Actual Completion Date
2022-08-15
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Has histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
* Failure of prior platinum therapy
* Radiographically-measurable disease based on RECIST 1.1
* Tumor tissue available for PD-L1 biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* Female participants of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of pembrolizumab or through 12
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
495
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
MASTERKEY-265
Identifier
NCT02263508
Link
https://clinicaltrials.gov/study/NCT02263508
Phase
Phase III
Status
Terminated
Sponsor
Amgen
More details
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma.
The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and overall survival (OS).
Purpose
Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-12-08
Anticipated Date of Last Follow-up
2022-11-10
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-03-11
Actual Completion Date
2021-03-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* Age ≥ 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery is not recommended.
* Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, renal, and coagulation function.
* Subjects with serine/threonine protein kinase B-Raf V600 (BRAFV600) wild-type tumors must not have received any prior systemic anticancer treatment consisting of chemotherapy, immunotherapy, or targeted therapy given in a non-adjuvant setting for unresectable stage IIIB to IVM1c melanoma.
* Subjects with B-Raf V600 (BRAFV600) mutated tumors who have rec
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
713
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-006
Identifier
NCT01866319
Link
https://clinicaltrials.gov/study/NCT01866319
Phase
Phase III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study will evaluate the safety and efficacy of 2 different dosing schedules of pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2 schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or metastatic melanoma. The primary hypotheses are that pembrolizumab is superior to ipilimumab with respect to progression-free survival (PFS) and overall survival (OS).
Purpose
Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2013-08-28
Anticipated Date of Last Follow-up
2020-05-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2015-03-03
Actual Completion Date
2019-06-03
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Histologically-confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma)
* At least one measurable lesion
* No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Archived tissue sample or new biopsy sample
* Female participants of childbearing potential must agree to use effective contraception from Visit 1 to 120 days after the last dose of study drug; male participants must agree to use an adequate method of contraception starting with the first dose of study drug throug
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
834
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
3475-010
Identifier
NCT01905657
Link
https://clinicaltrials.gov/study/NCT01905657
Phase
Phase II/III
Status
Completed
Sponsor
Merck Sharp & Dohme LLC
More details
This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.
Eligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met.
Protocol Amendment 12 (effective date
Purpose
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2013-08-09
Anticipated Date of Last Follow-up
2021-09-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2015-09-30
Actual Completion Date
2020-09-30
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Life expectancy of at least 3 months
* Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review
* At least one bi-dimensional measurable lesion
* Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
* Prior therapy with docetaxel for NSCLC
* Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
* Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
* Expe
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1034
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
