Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Study Summary

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions / Drugs

Pembrolizumab 200 mg Olaparib 400 mg Docetaxel 75 mg/m^2 Prednisone 5 mg Enzalutamide 160 mg Dexamethasone 8 mg Olaparib 300 mg Abiraterone acetate 1000 mg Lenvatinib Pembrolizumab/Vibostolimab coformulation Carboplatin Etoposide Belzutifan 120mg

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment1200 participants

Primary Completion—

Lead SponsorMerck Sharp & Dohme LLC

Data Retrieved2026-04-11 02:55:36.206012+00:00

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