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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

NCT04191135•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Induction Period:
•Has locally recurrent inoperable TNBC that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy
•Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician
•Has measurable disease based on RECIST 1.1
•Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment
•Has a life expectancy ≥27 weeks from the day of first study treatment
•Demonstrate adequate organ function within 10 days prior to the start of study treatment
•A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab)
•A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab)
+6 more criteria

Exclusion Criteria

•Induction Period:
•Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
•Has an active autoimmune disease that has required systemic treatment in the past 2 years
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
•Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
•Has a history of (non-infectious) pneumonitis\\interstitial lung disease that required steroids or current pneumonitis\\interstitial lung disease
•Has active, or a history of, interstitial lung disease
•Has a known history of active tuberculosis
•Has an active infection requiring systemic therapy
+31 more criteria

Locations (122)

Pacific Cancer Care ( Site 0142)

Monterey, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

San Francisco, California, United States

John Wayne Cancer Institute ( Site 0111)

Santa Monica, California, United States

St. Joseph Heritage Healthcare ( Site 0104)

Santa Rosa, California, United States

University of Miami Sylvester CC ( Site 0146)

Miami, Florida, United States

Georgia Cancer Center at Augusta University ( Site 0129)

Augusta, Georgia, United States

University of Chicago ( Site 0159)

Chicago, Illinois, United States

Massachusetts General Hospital ( Site 0155)

Boston, Massachusetts, United States

Henry Ford Health System ( Site 0103)

Detroit, Michigan, United States

Virginia Piper Cancer Institute ( Site 0157)

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 19, 2019

Primary Completion Date

December 15, 2022

Completion Date

November 26, 2025

Last Updated

March 3, 2026

Enrollment

462

ACTUAL participants

Conditions

Triple Negative Breast Neoplasms

Interventions

Pembrolizumab

BIOLOGICAL

Olaparib

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery

NCT05973864

Triple Negative Breast Neoplasms

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102

Triple Negative Breast Neoplasms

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ACTIVE_NOT_RECRUITINGPHASE3

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

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