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NCT03834506 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Prostatic Neoplasms, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,030
- Enrollment target
- 20
- Study locations
NCT03834506 is a Phase 3 study of Prostatic Neoplasms that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,030 participants, above the 498-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (107% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT03834506, a Phase 3 study of Prostatic Neoplasms, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,030 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 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
| Field | Value |
|---|---|
| Enrollment Target | 1,030 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2023-07-18 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,030 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 498-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (107% 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 5 interventions - of which Pembrolizumab is the first listed.
NCT03834506 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Michigan, Alabama.
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.
What interventions are being tested in trial NCT03834506?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Docetaxel (DRUG), Dexamethasone (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT03834506?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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