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-nave, 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
(RECIST 1.1) as assessed by blinded independent central review.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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