Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Public ClinicalTrials.gov record NCT03834519. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable.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.
Study identification
- NCT ID
- NCT03834519
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 793 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Olaparib Drug
- Abiraterone acetate Drug
- Prednisone Drug
- Enzalutamide Drug
- Prednisolone Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2019 (Actual)
- Primary completion
- Mar 14, 2022 (Actual)
- Completion
- Jan 27, 2024 (Actual)
- Last update posted
- May 18, 2025
2019 – 2024
United States locations
- U.S. sites
- 29
- U.S. states
- 20
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph Heritage Healthcare ( Site 0069) | Fullerton | California | 92835 | — |
| UCLA Hematology/Oncology - Santa Monica ( Site 0081) | Los Angeles | California | 90404 | — |
| Sibley Memorial Hospital ( Site 0096) | Washington D.C. | District of Columbia | 20016 | — |
| Georgia Cancer Center at Augusta University ( Site 0026) | Augusta | Georgia | 30912 | — |
| Quincy Medical Group ( Site 0021) | Quincy | Illinois | 62301 | — |
| Tulane Cancer Center ( Site 0066) | New Orleans | Louisiana | 70112 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005) | Baltimore | Maryland | 21287 | — |
| Chesapeake Urology Research Associates ( Site 0076) | Towson | Maryland | 21204 | — |
| Beth Israel Deaconess Medical Ctr. ( Site 0093) | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute ( Site 0033) | Boston | Massachusetts | 02215 | — |
| UMass Memorial Medical Center ( Site 0053) | Worcester | Massachusetts | 01655 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 0077) | Detroit | Michigan | 48201 | — |
| Henry Ford Health System ( Site 0039) | Detroit | Michigan | 48202 | — |
| St. Vincent Frontier Cancer Center ( Site 0016) | Billings | Montana | 59102 | — |
| Nebraska Cancer Specialists ( Site 0034) | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas | Nevada | 89169 | — |
| University of New Mexico Cancer Center ( Site 0048) | Albuquerque | New Mexico | 87131 | — |
| Memorial Medical Center ( Site 0095) | Las Cruces | New Mexico | 88011 | — |
| Associated Medical Professionals of NY ( Site 0060) | Syracuse | New York | 13210 | — |
| Duke Cancer Center Cary ( Site 0010) | Cary | North Carolina | 27511 | — |
| Gabrail Cancer Center-Research ( Site 0097) | Canton | Ohio | 44718 | — |
| The Urology Group- Cincinnati ( Site 0094) | Cincinnati | Ohio | 45212 | — |
| University Hospitals of Cleveland Seidman Cancer Center ( Site 0036) | Cleveland | Ohio | 44106 | — |
| Carolina Urologic Research Center ( Site 0070) | Myrtle Beach | South Carolina | 29572 | — |
| Huntsman Cancer Institute ( Site 0002) | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Institute ( Site 0052) | Richmond | Virginia | 23230 | — |
| Blue Ridge Cancer Care ( Site 0086) | Roanoke | Virginia | 24014 | — |
| Seattle Cancer Care Alliance ( Site 0079) | Seattle | Washington | 98109 | — |
| Froedtert and Medical College of Wisconsin ( Site 0045) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 164 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03834519, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03834519 live on ClinicalTrials.gov.