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NCT03740165 · ClinicalTrials.gov registry record · Phase 3
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
A Phase 3 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,367
- Enrollment target
- 20
- Study locations
NCT03740165: Active Phase 3 study of Ovarian Cancer and Fallopian Tube Cancer, sponsored by Merck Sharp & Dohme.
NCT03740165 is a Phase 3 study of Ovarian Cancer and Fallopian Tube Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,367 participants, above the 725-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740165, a Phase 3 study of Ovarian Cancer and Fallopian Tube Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,367 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1 positive tumors (CPS≥10) and in all participants.
Primary Outcome
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions and the unequivocal progression of non-target lesions is also
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Olaparib
- DRUG Paclitaxel
- DRUG Placebo for pembrolizumab
Study Locations (20)
California
- Disney Family Cancer Center ( Site 0042) - Burbank
- Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077) - Oakland
- Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084) - Roseville
- Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083) - Sacramento
- Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078) - San Francisco
- Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079) - Santa Clara
- Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008) - Vallejo
- Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080) - Walnut Creek
Georgia
- Emory School of Medicine ( Site 0053) - Atlanta
- Northeast Georgia Medical Center ( Site 0029) - Gainesville
- Memorial Health University Medical Center ( Site 0011) - Savannah
Illinois
- Rush University Medical Center ( Site 0019) - Chicago
- University of Chicago ( Site 0049) - Chicago
- Dr. Sudarshan K. Sharma, LTD ( Site 0061) - Hinsdale
Alabama
- University of Alabama at Birmingham (UAB) ( Site 0036) - Birmingham
Arizona
- University of Arizona Cancer Center ( Site 0074) - Tucson
Connecticut
- Smilow Cancer Center at Yale-New Haven ( Site 0057) - New Haven
Florida
- Sarasota Memorial Hospital ( Site 0023) - Sarasota
Indiana
- Saint Vincent Hospital and Health Center ( Site 0012) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,367 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2026-05-29 |
| Phase | Phase 3 |
What the registry record for NCT03740165 still lists
NCT03740165 is an interventional study that assigns participants to a tested intervention. Its 1,367 participants enrollment target places it among the larger protocols in the corpus, above the 725-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (89% higher).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03740165 names 20 study sites across 9 states, led by California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT03740165 about?
NCT03740165 is a clinical study titled "Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)". The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses ...
What is the current status of trial NCT03740165?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,367 participants. The study started on 2018-12-18. Estimated completion is 2026-05-29.
What conditions does trial NCT03740165 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms.
What interventions are being tested in trial NCT03740165?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Olaparib (DRUG), Paclitaxel (DRUG), Placebo for pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03740165?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740165 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03740165's enrollment target sits among peer trials
1,367 18th of 322 higher than 305 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
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