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ACTIVE NOT RECRUITING 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)

NCT03740165 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,367 participants
Start Date 2018-12-18
Est. Completion 2026-05-29
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03740165

The ClinicalTrials.gov registry entry for NCT03740165 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,367 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03740165 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03740165?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial