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NCT07811271
Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 600
Sponsor: BeOne Medicines
Summary
The purpose of this study is to evaluate the safety and efficacy of BG-C9074 with bevacizumab (Arm A) versus bevacizumab monotherapy (Arm B) in adults with epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after firstline platinum-based chemotherapy plus bevacizumab.
Eligibility Criteria
Inclusion Criteria:
1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
3. Participants must have a histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
4. Participants are newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage III or IV and have received primary debulking surgery or interval debulking surgery.
5. Participants must have adequate organ function.
6. Women of childbearing potential must be willing to use a highly effective method of birth control and agree not to donate eggs (ova, oocytes) or freeze/store eggs for the duration of the study and for ≥ 7 months after the last dose of study treatment.
Exclusion Criteria:
1. Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
2. Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
3. Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
4. Participants have a history of allergic reactions or hypersensitivity to the active ingredients and excipients of the drug products and other monoclonal antibodies.
5. Participants had previous transient ischemic attack, cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
6. Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07811271). StuddyBuddy aggregates publicly available trial information.