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NCT04123366 · ClinicalTrials.gov registry record · Phase 2
Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)
A Phase 2 study of Solid Tumors, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT04123366: Active Phase 2 study of Solid Tumors, sponsored by Merck Sharp & Dohme.
NCT04123366 is a Phase 2 study of Solid Tumors that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 300 participants, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04123366, a Phase 2 study of Solid Tumors, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.
Primary Outcome
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR for all participants will be presented by biomarker subgroup.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Olaparib
Study Locations (20)
California
- UC Davis Comprehensive Cancer Center ( Site 0039) - Sacramento
- San Francisco Oncology Associates ( Site 0085) - San Francisco
- University of California San Francisco ( Site 0015) - San Francisco
Georgia
- Winship Cancer Institute of Emory University ( Site 0057) - Atlanta
- Northeast Georgia Medical Center ( Site 0026) - Gainesville
- Northwest Georgia Oncology Centers PC ( Site 0047) - Marietta
Texas
- Parkland Health & Hospital System ( Site 0091) - Dallas
- University of Texas, Southwestern Medical Center ( Site 0004) - Dallas
- University of Texas-MD Anderson Cancer Center ( Site 0087) - Houston
Alabama
- The Kirklin Clinic ( Site 0086) - Birmingham
Arizona
- Banner MD Anderson Cancer Center ( Site 0049) - Gilbert
Colorado
- Banner MD Anderson Cancer Center ( Site 0092) - Greeley
Florida
- University of Florida ( Site 0078) - Gainesville
Kentucky
- Norton Cancer Institute - St. Matthews ( Site 0024) - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2026-07-23 |
| Phase | Phase 2 |
What the registry record for NCT04123366 still lists
NCT04123366 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target.
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04123366 names 20 study sites across 14 states, led by California, Georgia, Texas.
Frequently Asked Questions
What is clinical trial NCT04123366 about?
NCT04123366 is a clinical study titled "Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)". The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination...
What is the current status of trial NCT04123366?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2019-11-18. Estimated completion is 2026-07-23.
What conditions does trial NCT04123366 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT04123366?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Olaparib (DRUG).
Who is sponsoring clinical trial NCT04123366?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04123366 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04123366's enrollment target sits among peer trials
300 16th of 125 higher than 110 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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