Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

NCT07811271 | Not Yet Recruiting Phase 3 FDA Drug

• 5 other identifiers: BG-C9074-3012026-527172-84-00GOG-3144ENGOT-ov108APGOT-OV29
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to 5 years

• PFS, as Assessed by Investigator

  Up to 5 years

• PFS2, as Assessed by Investigator

  Up to 5 years

• Time to Next Treatment

  Up to 5 years

• Number of Participants with Treatment-Emergent Adverse Events, Treatment-Related Adverse Events, and Serious Adverse Events

  From first dose of study drug up to 30 days after last dose, up to 24 months

Study Arms (2)

Arm A: BG-C9074 + Bevacizumab

EXPERIMENTAL

BG-C9074 will be administered first, followed by bevacizumab.

Drug: BG-C9074; Drug: Bevacizumab

Arm B: Bevacizumab

ACTIVE COMPARATOR

Bevacizumab will be administered alone.

Drug: Bevacizumab

Interventions

BG-C9074 DRUG

Administered by Intravenous infusion

Arm A: BG-C9074 + Bevacizumab

Bevacizumab DRUG

Administered by Intravenous infusion

Arm A: BG-C9074 + Bevacizumab; Arm B: Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must have adequate organ function.
• 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.

You may not qualify if:

• 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.
• Participants had previous transient ischemic attack, cerebrovascular accident, or subarachnoid hemorrhage within 6 months prior to randomization
• Participants have evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).

Sponsors & Collaborators

• BeOne Medicines: lead
• 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

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

BeOne Medicines

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): March 31, 2033
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description