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NCT03834519 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
A Phase 3 study of Prostatic Neoplasms, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
- 20
- Study locations
NCT03834519 is a Phase 3 study of Prostatic Neoplasms that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 793 participants, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT03834519, a Phase 3 study of Prostatic Neoplasms, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per standard of care (SOC) schedule. In addition, electronic patient-reported outcome (ePRO) assessments will no longer be performed and biomarker samples will no longer be collected.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Olaparib
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone acetate
Study Locations (20)
Massachusetts
- Beth Israel Deaconess Medical Ctr. ( Site 0093) - Boston
- Dana Farber Cancer Institute ( Site 0033) - Boston
- UMass Memorial Medical Center ( Site 0053) - Worcester
California
- St. Joseph Heritage Healthcare ( Site 0069) - Fullerton
- UCLA Hematology/Oncology - Santa Monica ( Site 0081) - Los Angeles
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005) - Baltimore
- Chesapeake Urology Research Associates ( Site 0076) - Towson
Michigan
- Barbara Ann Karmanos Cancer Institute ( Site 0077) - Detroit
- Henry Ford Health System ( Site 0039) - Detroit
New Mexico
- University of New Mexico Cancer Center ( Site 0048) - Albuquerque
- Memorial Medical Center ( Site 0095) - Las Cruces
District of Columbia
- Sibley Memorial Hospital ( Site 0096) - Washington D.C.
Georgia
- Georgia Cancer Center at Augusta University ( Site 0026) - Augusta
Illinois
- Quincy Medical Group ( Site 0021) - Quincy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2024-01-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03834519
The ClinicalTrials.gov registry entry for NCT03834519 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 793 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 502-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (58% 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.
NCT03834519 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Massachusetts, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT03834519 about?
NCT03834519 is a clinical study titled "Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)". The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or e...
What is the current status of trial NCT03834519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2019-05-02. Estimated completion is 2024-01-27.
What conditions does trial NCT03834519 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT03834519?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Olaparib (DRUG), Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT03834519?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03834519 being conducted?
This trial has 20 study locations across California, District of Columbia, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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