Data from clinicaltrials.gov - Curated by EPG Health - Last updated 18 November 2019

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...

purpose

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-naïve, 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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date: July 28, 2019
Estimated Primary Completion Date: November 12, 2023
Estimated Study Completion Date: April 30, 2024

Arms:
- Experimental:
Pembrolizumab + Enzalutamide
- Placebo Comparator: Placebo + Enzalutamide

Category Value
Date last updated at source 14-Nov-19
Study type(s) Interventional
Expected enrolment 1200
Study start date 28-Jul-19
Estimated primary completion date 12-Nov-23

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