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 Response Evaluation Criteria in
Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
The China extension study will include participants previously enrolled in China in the
global study for MK-3475-921 (NCT03834506) plus those enrolled during the China extension
enrollment period. A total of approximately 150 Chinese participants will be enrolled.
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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