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NCT05116189 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
A Phase 3 study of Ovarian Cancer and Fallopian Tube Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
- 20
- Study locations
NCT05116189 is a Phase 3 study of Ovarian Cancer and Fallopian Tube Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 643 participants, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT05116189, a Phase 3 study of Ovarian Cancer and Fallopian Tube Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2027-07-16 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 643 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (12% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT05116189 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Indiana.
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.
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).
Who is sponsoring clinical trial NCT05116189?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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