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ACTIVE NOT RECRUITING

NCT05116189

PHASE3

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

643

Start Date

2021-12-13

Completion Date

2027-07-16

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Ovarian Cancer Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Bevacizumab

IV infusion

OTHER

Placebo for pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion

Inclusion Criteria: * Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-programmed cell death 1 protein (PD-1)/anti-programmed cell death ligand 1 (PD-L1) therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy. * Has provided documented informed consent for the study. * Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease). * Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using). * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization. * For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of \<1% per year). * Has radiographically evaluable disease, either measurable or nonmeasurable per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the local site investigator. * Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided. * Have adequate organ function. 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. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Has a known history of Hepatitis B or known active Hepatitis C virus infection. * Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study. * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study. * Has had an allogenic tissue/solid organ transplant. For bevacizumab treatment * Has uncontrolled hypertension. * Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam. * Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Locations (187)

HonorHealth ( Site 0041)

Phoenix, Arizona, United States

Marin Cancer Care ( Site 0055)

Greenbrae, California, United States

Pacific Cancer Care ( Site 0028)

Monterey, California, United States

Eisenhower Medical Center ( Site 0067)

Rancho Mirage, California, United States

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)

New Haven, Connecticut, United States

University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054

Gainesville, Florida, United States

Sarasota Memorial Hospital ( Site 0018)

Sarasota, Florida, United States

Moffitt Cancer Center ( Site 0033)

Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)

Marietta, Georgia, United States

Advocate Medical Group-Oncology ( Site 0049)

Park Ridge, Illinois, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0027)

Fort Wayne, Indiana, United States

St. Vincent Hospital and Health Care Center, Inc ( Site 0032)

Indianapolis, Indiana, United States

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)

Edgewood, Kentucky, United States

WK Physicians Network / Hematology Oncology Associates ( Site 0034)

Shreveport, Louisiana, United States

Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)

Baltimore, Maryland, United States

University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)

Worcester, Massachusetts, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)

Hackensack, New Jersey, United States

Roswell Park Cancer Institute ( Site 0039)

Buffalo, New York, United States

Columbia University Medical Center ( Site 0010)

New York, New York, United States

Novant Health Presbyterian Medical Center ( Site 0029)

Charlotte, North Carolina, United States

Duke Cancer Institute ( Site 0038)

Durham, North Carolina, United States

Novant Health Forsyth Medical Center ( Site 0057)

Winston-Salem, North Carolina, United States

Aultman Hospital-Oncology Clinical Trials ( Site 0009)

Canton, Ohio, United States

MetroHealth Medical Center-Cancer Care Center ( Site 0047)

Cleveland, Ohio, United States

Providence Portland Medical Center ( Site 0048)

Portland, Oregon, United States

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)

Pittsburgh, Pennsylvania, United States

Sanford Cancer Center ( Site 0064)

Sioux Falls, South Dakota, United States

The West Clinic, PLLC dba West Cancer Center ( Site 0058)

Germantown, Tennessee, United States

Texas Oncology - Dallas (Presbyterian) ( Site 0065)

Dallas, Texas, United States

Texas Oncology - The Woodlands_Lee ( Site 0043)

The Woodlands, Texas, United States

Inova Schar Cancer Institute ( Site 0019)

Fairfax, Virginia, United States

Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

Westmead, New South Wales, Australia

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)

Brisbane, Queensland, Australia

Epworth Freemasons ( Site 0204)

Melbourne, Victoria, Australia

St. John of God Subiaco Hospital ( Site 0203)

Subiaco, Western Australia, Australia

Institut Jules Bordet-Medicine Oncology ( Site 0302)

Brussels, Bruxelles-Capitale, Region de, Belgium

UZ Gent-Medical oncology ( Site 0301)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0303)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)

Kortrijk, West-Vlaanderen, Belgium

Hospital Araújo Jorge ( Site 0401)

Goiânia, Goiás, Brazil

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)

Natal, Rio Grande do Norte, Brazil

ANIMI - Unidade de Tratamento Oncologico ( Site 0408)

Lages, Santa Catarina, Brazil

BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)

São Paulo, São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)

São Paulo, São Paulo, Brazil

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)

Rio de Janeiro, Brazil

Tom Baker Cancer Center ( Site 0511)

Calgary, Alberta, Canada

BC Cancer Abbotsford ( Site 0512)

Abbotsford British Columbia, British Columbia, Canada

BC Cancer Victoria ( Site 0513)

Victoria, British Columbia, Canada

Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog

Kingston, Ontario, Canada

Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)

Toronto, Ontario, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0505)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0502)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Saskatoon Cancer Center ( Site 0510)

Saskatoon, Saskatchewan, Canada

Clínica Puerto Montt ( Site 0601)

Port Montt, Los Lagos Region, Chile

Oncovida ( Site 0603)