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ACTIVE NOT RECRUITING Phase 3

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

NCT05116189 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Bevacizumab
  • DRUG Docetaxel
  • DRUG Paclitaxel
  • OTHER Placebo for pembrolizumab

Study Locations (20)

California

  • Marin Cancer Care ( Site 0055) — Greenbrae
  • Pacific Cancer Care ( Site 0028) — Monterey
  • Eisenhower Medical Center ( Site 0067) — Rancho Mirage

Florida

  • University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 — Gainesville
  • Sarasota Memorial Hospital ( Site 0018) — Sarasota
  • Moffitt Cancer Center ( Site 0033) — Tampa

Indiana

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0027) — Fort Wayne
  • St. Vincent Hospital and Health Care Center, Inc ( Site 0032) — Indianapolis

New York

  • Roswell Park Cancer Institute ( Site 0039) — Buffalo
  • Columbia University Medical Center ( Site 0010) — New York

Arizona

  • HonorHealth ( Site 0041) — Phoenix

Connecticut

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) — New Haven

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) — Marietta

Illinois

  • Advocate Medical Group-Oncology ( Site 0049) — Park Ridge

Trial Details

FieldValue
Enrollment Target 643 participants
Start Date 2021-12-13
Est. Completion 2027-07-16
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 NCT05116189

The ClinicalTrials.gov registry entry for NCT05116189 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 643 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: NCT05116189 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Indiana. 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 NCT05116189 about?

NCT05116189 is a clinical study titled "Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).". The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hyp...

What is the current status of trial NCT05116189?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2021-12-13. Estimated completion is 2027-07-16.

What conditions does trial NCT05116189 study?

This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05116189?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Bevacizumab (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Placebo for pembrolizumab (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05116189?

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 NCT05116189 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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