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Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.
Study details:
Assignment of patients to a cohort will be based on prior treatment as outlined in the eligibility criteria. Participants who discontinue pembrolizumab or vibostolimab+pembrolizumab after 35 infusions for reasons other than disease progression or intolerability, or who discontinue pembrolizumab or coformulation of pembrolizumab/vibostolimab after attaining a complete response (and had at least 8 administrations of pembrolizumab or pembrolizumab/vibostolimab coformulation and at least 2 treatments with pembrolizumab or pembrolizumab/vibostolimab coformulation beyond initial complete response) may be eligible to receive a second course of treatment that includes up to 17 additional infusions (approximately 1 year) of pembrolizumab monotherapy or pembrolizumab/vibostolimab coformulation after they have experienced radiographic disease progression after stopping first course treatment. Effective with Protocol Amendment 08, enrollment into Cohorts A, B, C, and D was closed.
Effective with Protocol Amendment 14, enrollment into Cohorts E, F, G, and H was closed (not due to any safety issues). No further efficacy and survival follow-up assessments will be collected in Cohorts A through H. Effective with Protocol Amendment 16, enrollment into Cohort J was closed (not due to any safety issues).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2016-11-17
Primary completion: 2027-10-22
Study completion finish: 2027-10-22
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT02861573
Intervention or treatment
BIOLOGICAL: Pembrolizumab 200 mg
DRUG: Olaparib 400 mg
DRUG: Docetaxel 75 mg/m^2
DRUG: Prednisone 5 mg
DRUG: Enzalutamide 160 mg
OTHER: Dexamethasone 8 mg
DRUG: Olaparib 300 mg
DRUG: Abiraterone acetate 1000 mg
DRUG: Lenvatinib
BIOLOGICAL: Pembrolizumab/Vibostolimab coformulation
DRUG: Carboplatin
DRUG: Etoposide
BIOLOGICAL: Belzutifan 120mg
Conditions
- • Metastatic Castration-Resistant Prostate Cancer
Find a site
Closest Location:
MSD Australia
Research sites nearby
Select from list below to view details:
MSD Australia
North Ryde, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Pembrolizumab+Olaparib
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab+Docetaxel+Prednisone
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab+Enzalutamide
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab+Abiraterone+Prednisone
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab+Lenvatinib: AC
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab+Lenvatinib:t-NE
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Pembrolizumab/Vibostolimab coformulation
| BIOLOGICAL: Pembrolizumab/Vibostolimab coformulation
|
EXPERIMENTAL: Pembrolizumab/Vibostolimab coformulation:t-NE
| BIOLOGICAL: Pembrolizumab/Vibostolimab coformulation
|
EXPERIMENTAL: Pembrolizumab+Carboplatin+Etoposide
| BIOLOGICAL: Pembrolizumab 200 mg
|
EXPERIMENTAL: Carboplatin+Etoposide
| DRUG: Carboplatin
|
EXPERIMENTAL: Belzutifan
| BIOLOGICAL: Belzutifan 120mg
|
EXPERIMENTAL: Pembrolizumab+Belzutifan
| BIOLOGICAL: Pembrolizumab 200 mg
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA) | Not Specified | From Baseline Measured Every 3 Weeks Until Radiographic Progression Estimated to be Approximately 2 Years |
Number of Participants with Adverse Events (AEs) | Not Specified | Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Number of Participants Discontinuing Study Drug Due to AEs | Not Specified | Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Disease Control Rate (DCR) Based on Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 Assessed by BICR | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Overall Survival (OS) | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
ORR Based on PCWG3-modified RECIST 1.1 Assessed by BICR | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Time to PSA Progression | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Radiographic Progression-free Survival (rPFS) Based on PCWG3-modified RECIST 1.1 Assessed by BICR | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only) | Not Specified | Assessed Over the Duration of the Study Which is Estimated to be Approximately 2 Years |
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