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)
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT03834493
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pembrolizumab — BIOLOGICALIV infusion
- Enzalutamide — DRUGCapsules/Tablets
- Placebo — DRUGIV infusion
Study Details
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.
Key Dates
- First listed
- Feb 8, 2019
- Start date
- Jul 28, 2019
- Status verified
- Jun 2026
- Primary completion
- Dec 12, 2022
- Completion
- Jun 8, 2026
Study Design
- Enrollment
- 1,244 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pembrolizumab + EnzalutamideParticipants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.
- Placebo Comparator: Placebo + EnzalutamideParticipants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.
Primary Outcome Measure
Overall Survival (OS) [ Time Frame: Up to 40 months (through database cut-off date of 12-Dec-2022) ]
Locations (28)
Related coverage on Hipa.ai
- Pembrolizumab Fails to Improve OS in Metastatic Castration-Resistant Prostate…Pembrolizumab · Dec 12, 2022 · ClinicalTrials.gov
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