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COMPLETED Phase 3

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

NCT03834506 · 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 docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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 Docetaxel
  • DRUG Dexamethasone
  • DRUG Prednisone

Study Locations (20)

California

  • St. Joseph Heritage Healthcare ( Site 0069) — Fullerton
  • University of Southern California Norris Comprehensive Cancer Center ( Site 0061) — Los Angeles
  • USC Norris Oncology Hematology Newport Beach ( Site 0093) — Newport Beach
  • University of California San Francisco ( Site 0023) — San Francisco

Michigan

  • Karmanos Cancer Institute ( Site 0077) — Detroit
  • Henry Ford Health System ( Site 0039) — Detroit
  • Cancer & Hematology Centers of Western Michigan ( Site 0013) — Grand Rapids

Alabama

  • University of South Alabama, Mitchell Cancer Institute ( Site 0065) — Mobile

Colorado

  • University of Colorado Cancer Center ( Site 0022) — Aurora

Connecticut

  • Yale Cancer Center ( 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 Medical Center ( Site 0042) — Chicago

Trial Details

FieldValue
Enrollment Target 1,030 participants
Start Date 2019-05-02
Est. Completion 2023-07-18
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 NCT03834506

The ClinicalTrials.gov registry entry for NCT03834506 describes a study currently listed as completed. 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 1,030 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 5 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: NCT03834506 reports 20 study locations spanning 15 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 NCT03834506 about?

NCT03834506 is a clinical study titled "Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)". The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Nex...

What is the current status of trial NCT03834506?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,030 participants. The study started on 2019-05-02. Estimated completion is 2023-07-18.

What conditions does trial NCT03834506 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 NCT03834506?

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

Who is sponsoring clinical trial NCT03834506?

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 NCT03834506 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