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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04123366
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Oral tablet
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Nov 18, 2019
Status verified
Apr 2026
Primary completion
Jun 29, 2026
Completion
Jun 29, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib+Pembrolizumab
    Participants receive olaparib 300 mg via oral tablet 2 times each day PLUS pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Participants may receive olaparib+pembrolizumab for up to approximately 2 years.

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups [ Time Frame: Up to ~3 years ]

Locations (21)

FacilityCityStateZIPSite coordinators
The Kirklin Clinic ( Site 0086)BirminghamAlabama35233-
Banner MD Anderson Cancer Center ( Site 0049)GilbertArizona85234-
UC Davis Comprehensive Cancer Center ( Site 0039)SacramentoCalifornia95817-
San Francisco Oncology Associates ( Site 0085)San FranciscoCalifornia94115-
University of California San Francisco ( Site 0015)San FranciscoCalifornia94158-
Banner MD Anderson Cancer Center ( Site 0092)GreeleyColorado80631-
University of Florida ( Site 0078)GainesvilleFlorida32608-
Winship Cancer Institute of Emory University ( Site 0057)AtlantaGeorgia30322-
Northeast Georgia Medical Center ( Site 0026)GainesvilleGeorgia30501-
Northwest Georgia Oncology Centers PC ( Site 0047)MariettaGeorgia30060-
Norton Cancer Institute - St. Matthews ( Site 0024)LouisvilleKentucky40207-
Atlantic Health System ( Site 0046)SummitNew Jersey07901-
New York Cancer and Blood Specialists-Research Department ( Site 0080)Port Jefferson StationNew York11776-
University Hospitals Cleveland Medical Center ( Site 0016)ClevelandOhio44106-
The University of Oklahoma Health Sciences Center ( Site 0050)Oklahoma CityOklahoma73104-
Parkland Health & Hospital System ( Site 0091)DallasTexas75235-
University of Texas, Southwestern Medical Center ( Site 0004)DallasTexas75390-
University of Texas-MD Anderson Cancer Center ( Site 0087)HoustonTexas77030-
Utah Cancer Specialists ( Site 0038)West Valley CityUtah84119-
Inova Schar Cancer Institute ( Site 0008)FairfaxVirginia22031-
Northwest Medical Specialties, PLLC ( Site 0007)TacomaWashington98405-

Find similar trials in Birmingham, AL

By research site
The Kirklin Clinic· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZUC Davis Comprehensive Cancer Center· Sacramento, CASan Francisco Oncology Associates· San Francisco, CAUniversity of California San Francisco· San Francisco, CABanner MD Anderson Cancer Center· Greeley, CO

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