Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). (NCT05116189)
🩺 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 \[CPS\] ≥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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (27 items).
Location: HonorHealth ( Site 0041) — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
- Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
- Has prior disease progression on weekly paclitaxel alone.
- Has received \>2 prior lines of systemic therapy for OC.
- Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
- Has received prior radiation therapy within 2 weeks of start of study intervention.
- Has not recovered adequately from surgery and/or any complications from the surgery.
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor,\[GM-CSF\] or recombinant erythropoietin) within 4 weeks before randomization.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (187 Sites)
- HonorHealth ( Site 0041) — Phoenix, Arizona
- Marin Cancer Care ( Site 0055) — Greenbrae, California
- Pacific Cancer Care ( Site 0028) — Monterey, California
- Eisenhower Medical Center ( Site 0067) — Rancho Mirage, California
- Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) — New Haven, Connecticut
- University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 — Gainesville, Florida
- Sarasota Memorial Hospital ( Site 0018) — Sarasota, Florida
- Moffitt Cancer Center ( Site 0033) — Tampa, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) — Marietta, Georgia
- Advocate Medical Group-Oncology ( Site 0049) — Park Ridge, Illinois
- Parkview Research Center at Parkview Regional Medical Center ( Site 0027) — Fort Wayne, Indiana
- St. Vincent Hospital and Health Care Center, Inc ( Site 0032) — Indianapolis, Indiana
- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) — Edgewood, Kentucky
- WK Physicians Network / Hematology Oncology Associates ( Site 0034) — Shreveport, Louisiana
- Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) — Baltimore, Maryland
- University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) — Worcester, Massachusetts
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) — Hackensack, New Jersey
- Roswell Park Cancer Institute ( Site 0039) — Buffalo, New York
- Columbia University Medical Center ( Site 0010) — New York, New York
- Novant Health Presbyterian Medical Center ( Site 0029) — Charlotte, North Carolina
- Duke Cancer Institute ( Site 0038) — Durham, North Carolina
- Novant Health Forsyth Medical Center ( Site 0057) — Winston-Salem, North Carolina
- Aultman Hospital-Oncology Clinical Trials ( Site 0009) — Canton, Ohio
- MetroHealth Medical Center-Cancer Care Center ( Site 0047) — Cleveland, Ohio
- Providence Portland Medical Center ( Site 0048) — Portland, Oregon
💰 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 § 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.