Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Part of paid clinical trials in Monterey, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04191135
Phase
PHASE2
Status
Completed

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    intravenous (IV) infusion
  • Olaparib — DRUG
    oral tablets
  • Carboplatin — DRUG
    IV infusion
  • Gemcitabine — DRUG
    IV infusion

Study Details

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.

Key Dates

Start date
Dec 19, 2019
Status verified
Feb 2026
Primary completion
Dec 15, 2022
Completion
Nov 26, 2025

Study Design

Enrollment
462 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Olaparib
    This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.
  • Experimental: Pembrolizumab + Carboplatin + Gemcitabine
    This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 29 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Pacific Cancer Care ( Site 0142)MontereyCalifornia93940-
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)San FranciscoCalifornia94158-
John Wayne Cancer Institute ( Site 0111)Santa MonicaCalifornia90404-
St. Joseph Heritage Healthcare ( Site 0104)Santa RosaCalifornia95403-
University of Miami Sylvester CC ( Site 0146)MiamiFlorida33136-
Georgia Cancer Center at Augusta University ( Site 0129)AugustaGeorgia30912-
University of Chicago ( Site 0159)ChicagoIllinois60637-
Massachusetts General Hospital ( Site 0155)BostonMassachusetts02114-
Henry Ford Health System ( Site 0103)DetroitMichigan48202-
Virginia Piper Cancer Institute ( Site 0157)MinneapolisMinnesota55407-
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)MiddletownNew Jersey07748-
MSKCC-Bergen ( Site 0162)MontvaleNew Jersey07645-
Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)CommackNew York11725-
Memorial Sloan-Kettering Cancer Center ( Site 0156)New YorkNew York10065-
Mercy Clinic Oncology and Hematology ( Site 0110)Oklahoma CityOklahoma73120-
The Center For Cancer And Blood Disorders ( Site 0151)Fort WorthTexas76104-
Texas Oncology-New Braunfels ( Site 0168)New BraunfelsTexas78130-
Texas Oncology - San Antonio Stone Oak ( Site 0166)San AntonioTexas78258-
Texas Oncology-San Antonio Medical Center ( Site 0158)San AntonioTexas78240-
Texas Oncology-San Antonio Northeast ( Site 0165)San AntonioTexas78217-
Renovatio Clinical ( Site 0117)The WoodlandsTexas77380-
Virginia Oncology Associates ( Site 0163)Newport NewsVirginia23606-
Virginia Oncology Associates ( Site 0153)NorfolkVirginia23502-
Virginia Oncology Associates ( Site 0164)Virginia BeachVirginia23456-
YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)YakimaWashington98902-

Find similar trials in Monterey, CA

By research site
Pacific Cancer Care· Monterey, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAJohn Wayne Cancer Institute· Santa Monica, CASt. Joseph Heritage Healthcare· Santa Rosa, CAUniversity of Miami Sylvester CC· Miami, FLGeorgia Cancer Center at Augusta University· Augusta, GA

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