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.
Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Participants must have a histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (serous, endometrioid, or clear cell).
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.
Participants have ovarian, fallopian tube, or peritoneal cancer of nonepithelial origin.
Participants have either a germline or somatic BReast CAncer gene (BRCA) mutation as per local test.
Participants who will receive poly-adenosine diphosphate ribose polymerase (PARP) inhibitor as maintenance therapy per standard of care and investigator discretion.
Participants have a history of allergic reactions or hypersensitivity to the active ingredients and excipients of the drug products and other monoclonal antibodies.
Parallel
BG-C9074
DrugAdministered by Intravenous infusion
Bevacizumab
DrugAdministered by Intravenous infusion
Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the date of disease progression by BICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any reason.
PFS, as Assessed by Investigator
PFS is defined as time from randomization to the date of disease progression by Investigator based on RECIST v1.1 or death, whichever occurs first.
PFS2, as Assessed by Investigator
PFS2, as assessed by investigator, is defined as time from randomization to the documented disease progression on first subsequent systemic therapy by Investigator or death due to any cause, whichever occurs first.
Time to Next Treatment
Time to next treatment is defined as the time from randomization to the start of the first subsequent anticancer therapy after discontinuation of randomized treatment, or death due to any cause.
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BeOne Medicines
Lead sponsor
GOG Foundation
Collaborator
Latin American Cooperative Oncology Group (LACOG)
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Asia-Pacific Gynecologic Oncology Trials Group
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
