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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 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 462 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191135
The ClinicalTrials.gov registry entry for NCT04191135 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04191135 reports 0 study locations.
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.
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