Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
Public ClinicalTrials.gov record NCT05116189. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05116189
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 643 participants
Conditions and interventions
Interventions
- Pembrolizumab Biological
- Paclitaxel Drug
- Bevacizumab Drug
- Placebo for pembrolizumab Other
- Docetaxel Drug
Biological · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2021 (Actual)
- Primary completion
- Mar 5, 2025 (Actual)
- Completion
- Jul 16, 2027 (Estimated)
- Last update posted
- Mar 9, 2026
2021 – 2027
United States locations
- U.S. sites
- 31
- U.S. states
- 21
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth ( Site 0041) | Phoenix | Arizona | 85016 | — |
| Marin Cancer Care ( Site 0055) | Greenbrae | California | 94904 | — |
| Pacific Cancer Care ( Site 0028) | Monterey | California | 93940 | — |
| Eisenhower Medical Center ( Site 0067) | Rancho Mirage | California | 92270 | — |
| Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) | New Haven | Connecticut | 06511 | — |
| University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 | Gainesville | Florida | 32610 | — |
| Sarasota Memorial Hospital ( Site 0018) | Sarasota | Florida | 34239 | — |
| Moffitt Cancer Center ( Site 0033) | Tampa | Florida | 33612 | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) | Marietta | Georgia | 30060 | — |
| Advocate Medical Group-Oncology ( Site 0049) | Park Ridge | Illinois | 60068 | — |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0027) | Fort Wayne | Indiana | 46845 | — |
| St. Vincent Hospital and Health Care Center, Inc ( Site 0032) | Indianapolis | Indiana | 46260 | — |
| Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) | Edgewood | Kentucky | 41017 | — |
| WK Physicians Network / Hematology Oncology Associates ( Site 0034) | Shreveport | Louisiana | 71103 | — |
| Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) | Baltimore | Maryland | 21202 | — |
| University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) | Worcester | Massachusetts | 01605 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute ( Site 0039) | Buffalo | New York | 14263 | — |
| Columbia University Medical Center ( Site 0010) | New York | New York | 10032 | — |
| Novant Health Presbyterian Medical Center ( Site 0029) | Charlotte | North Carolina | 28204 | — |
| Duke Cancer Institute ( Site 0038) | Durham | North Carolina | 27710 | — |
| Novant Health Forsyth Medical Center ( Site 0057) | Winston-Salem | North Carolina | 27103 | — |
| Aultman Hospital-Oncology Clinical Trials ( Site 0009) | Canton | Ohio | 44710 | — |
| MetroHealth Medical Center-Cancer Care Center ( Site 0047) | Cleveland | Ohio | 44109 | — |
| Providence Portland Medical Center ( Site 0048) | Portland | Oregon | 97213 | — |
| University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024) | Pittsburgh | Pennsylvania | 15219 | — |
| Sanford Cancer Center ( Site 0064) | Sioux Falls | South Dakota | 57104 | — |
| The West Clinic, PLLC dba West Cancer Center ( Site 0058) | Germantown | Tennessee | 38138 | — |
| Texas Oncology - Dallas (Presbyterian) ( Site 0065) | Dallas | Texas | 75231 | — |
| Texas Oncology - The Woodlands_Lee ( Site 0043) | The Woodlands | Texas | 77380 | — |
| Inova Schar Cancer Institute ( Site 0019) | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 156 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05116189, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05116189 live on ClinicalTrials.gov.