Metastatic Prostate Cancer Treatment
common.study.values.description
“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)”
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-naA?ve, 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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
Biological - Pembrolizumab
IV infusion
Drug - Enzalutamide
Capsules/Tablets
Drug - Placebo
IV infusion
participant.views.study.view.additional
participant.views.study.view.scientific-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)
common.study.values.clinical-trial-id
NCT03834493
participant.views.study.view.id
epYVXa
