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NCT03834493 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Prostatic Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,244
- Enrollment target
- 20
- Study locations
NCT03834493 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,244 participants, above the 495-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 18 states.
The verdict
NCT03834493, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,244 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Enzalutamide
Study Locations (20)
California
- Providence Medical Foundation-Oncology ( Site 0069) - Fullerton
- UCLA Hematology/Oncology - Santa Monica ( Site 0081) - Los Angeles
Michigan
- Cancer & Hematology Centers of Western Michigan ( Site 0013) - Grand Rapids
- Munson Medical Center ( Site 0030) - Traverse City
Alabama
- University of South Alabama, Mitchell Cancer Institute ( Site 0065) - Mobile
Colorado
- University of Colorado Cancer Center ( Site 0022) - Aurora
Connecticut
- Smilow Cancer Hospital at Yale New Haven ( Site 0038) - New Haven
Florida
- Moffitt Cancer Center ( Site 0080) - Tampa
Georgia
- Georgia Cancer Center at Augusta University ( Site 0026) - Augusta
Illinois
- Mount Sinai Hospital ( Site 0042) - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,244 participants |
| Start Date | 2019-07-28 |
| Est. Completion | 2026-05-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03834493
The ClinicalTrials.gov registry entry for NCT03834493 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,244 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 495-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (151% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03834493 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Michigan, Alabama.
Frequently Asked Questions
What is clinical trial NCT03834493 about?
NCT03834493 is a clinical study titled "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-naïve, or are intolerant to...
What is the current status of trial NCT03834493?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,244 participants. The study started on 2019-07-28. Estimated completion is 2026-05-29.
What conditions does trial NCT03834493 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT03834493?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT03834493?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03834493 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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