A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

Protocol No
MERCK-MK-3475-641
Principal Investigator
Kathryn Bylow
Phase
III
Summary
The purpose of this study is to: * Test the safety of the study drugs, Pembrolizumab in combination with a hormone drug (Enzalutamide) for prostate cancer * See how well your body handles Pembrolizumab compared to placebo (a look-alike with no active ingredients) in combination with Enzalutamide * See how well Pembrolizumab compared to placebo works in combination Enzalutamide * See if Pembrolizumab in combination with Enzalutamide helps patients have a better quality of life * See if Pembrolizumab in combination with Enzalutamide helps patients live longer Pembrolizumab has been approved for patients with certain types of cancer; however, it has not been approved for your type of prostate cancer. Enzalutamide has been approved for patients with your type of prostate cancer. We don't know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for prostate cancer in the future.
Description
Phase 3 Study of Pembrolizumab/Placebo plus Enzalutamide in mCRPC
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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