Lay Title: KEYNOTE-641: A Study comparing Enzalutamide with or without Pembrolizumab in Metastatic Prostate Cancer
Technical Title: 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)
Disease Type: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Basic information: The purpose of this study is to evaluate if Pembrolizumab combined with Enzalutamide provides benefit compared to Enzalutamide alone in metastatic, castration-resistant prostate cancer (mCRPC). Pembrolizumab is an intravenous (into the vein) immunotherapy. Enzalutamide is an FDA-approved oral treatment for mCRPC.
Research Procedures (not a complete list): Once you begin treatment, you will need to come to clinic every 3 weeks for the duration of your participation in the study. You will need to return for scans every 9 weeks for the first year of the study, and then every 12 weeks after that.
Eligibility Criteria (not a complete list):
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ClinicalTrials.gov Identifier: NCT03834493