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- (KEYNOTE-641) 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)
Clinical Trial
(KEYNOTE-641) 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)
The purpose of this study is to test the safety of the study drug, pembrolizumab in combination with a hormone drug (enzalutamide) for prostate cancer. Other aims of the study are to 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 and see if pembrolizumab in combination with enzalutamide helps patients live longer.
- Urinary System
- Cancer
- Enzalutamide
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Multicenter
- Pembrolizumab (MK-3475)
Eligibility Criteria
- Patients must be 18 years of age or older Have histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. Diagnosis must be stated in a pathology report and confirmed by the investigator. Have prostate cancer progression while on ADT (or post bilateral orchiectomy (removal of testicles)) within 6 months prior to screening, as determined by the investigator Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by CT/MRI.
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