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ACTIVE NOT RECRUITING 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)

NCT03834493 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 1,244 participants
Start Date 2019-07-28
Est. Completion 2026-05-29
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03834493 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Michigan, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03834493?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03834493?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial