Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). (NCT05116189)
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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 \[CPS\] โฅ1) 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.
Who can join: Review the eligibility criteria below.
Location: HonorHealth ( Site 0041) โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (187 Sites)
Showing the first 25 of 187 sites.
- HonorHealth ( Site 0041) โ Phoenix, Arizona
- Marin Cancer Care ( Site 0055) โ Greenbrae, California
- Pacific Cancer Care ( Site 0028) โ Monterey, California
- Eisenhower Medical Center ( Site 0067) โ Rancho Mirage, California
- Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) โ New Haven, Connecticut
- University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 โ Gainesville, Florida
- Sarasota Memorial Hospital ( Site 0018) โ Sarasota, Florida
- Moffitt Cancer Center ( Site 0033) โ Tampa, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) โ Marietta, Georgia
- Advocate Medical Group-Oncology ( Site 0049) โ Park Ridge, Illinois
- Parkview Research Center at Parkview Regional Medical Center ( Site 0027) โ Fort Wayne, Indiana
- St. Vincent Hospital and Health Care Center, Inc ( Site 0032) โ Indianapolis, Indiana
- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) โ Edgewood, Kentucky
- WK Physicians Network / Hematology Oncology Associates ( Site 0034) โ Shreveport, Louisiana
- Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) โ Baltimore, Maryland
- University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) โ Worcester, Massachusetts
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) โ Hackensack, New Jersey
- Roswell Park Cancer Institute ( Site 0039) โ Buffalo, New York
- Columbia University Medical Center ( Site 0010) โ New York, New York
- Novant Health Presbyterian Medical Center ( Site 0029) โ Charlotte, North Carolina
- Duke Cancer Institute ( Site 0038) โ Durham, North Carolina
- Novant Health Forsyth Medical Center ( Site 0057) โ Winston-Salem, North Carolina
- Aultman Hospital-Oncology Clinical Trials ( Site 0009) โ Canton, Ohio
- MetroHealth Medical Center-Cancer Care Center ( Site 0047) โ Cleveland, Ohio
- Providence Portland Medical Center ( Site 0048) โ Portland, Oregon
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Cancer
- Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy โ New York, New York
- Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer โ Pittsburgh, Pennsylvania
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer โ New York, New York
- Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) โ Duarte, California
- Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) โ Little Rock, Arkansas
- NeoVax With Nivolumab in Patients With Ovarian Cancer โ Boston, Massachusetts
Explore by condition: All Ovarian Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.