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ACTIVE NOT RECRUITING 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)

NCT04123366 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 300 participants
Start Date 2019-11-18
Est. Completion 2026-07-23
Phase Phase 2

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04123366

The ClinicalTrials.gov registry entry for NCT04123366 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 300 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 Solid Tumors appearing as the primary indexed condition, and to 2 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: NCT04123366 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Georgia, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04123366?

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

Who is sponsoring clinical trial NCT04123366?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial