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)
Public ClinicalTrials.gov record NCT04191135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04191135
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 462 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Olaparib Drug
- Carboplatin Drug
- Gemcitabine Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2019
- Primary completion
- Dec 14, 2022
- Completion
- Nov 25, 2025
- Last update posted
- Sep 13, 2026
2019 – 2025
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Cancer Care ( Site 0142) | Monterey | California | 93940 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138) | San Francisco | California | 94158 | — |
| John Wayne Cancer Institute ( Site 0111) | Santa Monica | California | 90404 | — |
| St. Joseph Heritage Healthcare ( Site 0104) | Santa Rosa | California | 95403 | — |
| University of Miami Sylvester CC ( Site 0146) | Miami | Florida | 33136 | — |
| Georgia Cancer Center at Augusta University ( Site 0129) | Augusta | Georgia | 30912 | — |
| University of Chicago ( Site 0159) | Chicago | Illinois | 60637 | — |
| Massachusetts General Hospital ( Site 0155) | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System ( Site 0103) | Detroit | Michigan | 48202 | — |
| Virginia Piper Cancer Institute ( Site 0157) | Minneapolis | Minnesota | 55407 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161) | Middletown | New Jersey | 07748 | — |
| MSKCC-Bergen ( Site 0162) | Montvale | New Jersey | 07645 | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160) | Commack | New York | 11725 | — |
| Memorial Sloan-Kettering Cancer Center ( Site 0156) | New York | New York | 10065 | — |
| Mercy Clinic Oncology and Hematology ( Site 0110) | Oklahoma City | Oklahoma | 73120 | — |
| The Center For Cancer And Blood Disorders ( Site 0151) | Fort Worth | Texas | 76104 | — |
| Texas Oncology-New Braunfels ( Site 0168) | New Braunfels | Texas | 78130 | — |
| Texas Oncology-San Antonio Northeast ( Site 0165) | San Antonio | Texas | 78217 | — |
| Texas Oncology-San Antonio Medical Center ( Site 0158) | San Antonio | Texas | 78240 | — |
| Texas Oncology - San Antonio Stone Oak ( Site 0166) | San Antonio | Texas | 78258 | — |
| Renovatio Clinical ( Site 0117) | The Woodlands | Texas | 77380 | — |
| Virginia Oncology Associates ( Site 0163) | Newport News | Virginia | 23606 | — |
| Virginia Oncology Associates ( Site 0153) | Norfolk | Virginia | 23502 | — |
| Virginia Oncology Associates ( Site 0164) | Virginia Beach | Virginia | 23456 | — |
| YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128) | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 97 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04191135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2026 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04191135 live on ClinicalTrials.gov.