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NCT04191135 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 462
- Enrollment target
NCT04191135: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT04191135 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 462 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191135, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 462 participants
- Enrollment target
Study 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.
Primary Outcome
PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Olaparib
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2025-11-26 |
| Phase | Phase 2 |
What the finished NCT04191135 record still lists
NCT04191135 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (247% higher).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04191135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04191135 about?
NCT04191135 is a clinical study titled "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)". 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 pembroli...
What is the current status of trial NCT04191135?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 462 participants. The study started on 2019-12-19. Estimated completion is 2025-11-26.
What interventions are being tested in trial NCT04191135?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Olaparib (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT04191135?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04191135's enrollment target sits among peer trials
462 82nd of 2000 higher than 1,919 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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