Last updated on September 2020

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)


Brief description of study

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.

Clinical Study Identifier: NCT03834493

Find a site near you

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Methodist Hospitals. ( Site 0008)

Merrillville, IN United States
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Munson Medical Center ( Site 0030)

Traverse City, MI United States
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Macquarie University ( Site 0151)

Macquarie University, Australia
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Tulane Cancer Center ( Site 0066)

New Orleans, LA United States
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EMC ( Site 0559)

Moscow, Russian Federation
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Recruitment Status: Open


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