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Clinical Trials in Ireland / NCT05116189
Active, not recruiting Phase 3

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

NCT05116189 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2021-12-13
Last updated
2026-03-09

Condition(s) studied

Ovarian CancerCarcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Investigational drug(s) / intervention(s)

PembrolizumabPaclitaxelBevacizumabPlacebo for pembrolizumabDocetaxel

Pembrolizumab: IV infusion

Paclitaxel: IV infusion

Bevacizumab: IV infusion

Placebo for pembrolizumab: IV infusion

Docetaxel: IV infusion

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (187)

FacilityCityRegionStatus
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
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024) Pittsburgh Pennsylvania
Sanford Cancer Center ( Site 0064) Sioux Falls South Dakota
The West Clinic, PLLC dba West Cancer Center ( Site 0058) Germantown Tennessee
Texas Oncology - Dallas (Presbyterian) ( Site 0065) Dallas Texas
Texas Oncology - The Woodlands_Lee ( Site 0043) The Woodlands Texas
Inova Schar Cancer Institute ( Site 0019) Fairfax Virginia
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201) Westmead New South Wales
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202) Brisbane Queensland
Epworth Freemasons ( Site 0204) Melbourne Victoria
St. John of God Subiaco Hospital ( Site 0203) Subiaco Western Australia
Institut Jules Bordet-Medicine Oncology ( Site 0302) Brussels Bruxelles-Capitale, Region de
UZ Gent-Medical oncology ( Site 0301) Ghent Oost-Vlaanderen
UZ Leuven ( Site 0303) Leuven Vlaams-Brabant
AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305) Kortrijk West-Vlaanderen
Hospital Araújo Jorge ( Site 0401) Goiânia Goiás

+ 147 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05116189 on ClinicalTrials.gov ↗ ← All trials in Ireland