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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: Active Phase 3 study of Ovarian Cancer and Fallopian Tube Neoplasms, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appear
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 |
What the registry record for NCT05116189 still lists
NCT05116189 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (12% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT05116189's enrollment target sits among peer trials
643 35th of 322 higher than 288 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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