Clinical trial · Interventional
Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
A Phase 3, Open-label, Multicenter, Randomized Study of BG-C9074 With Bevacizumab Versus Bevacizumab as First-line Maintenance Therapy for Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After First-line Platinum-based Chemotherapy Plus Bevacizumab (Starstone-Ovarian 301/GOG-3144/ENGOT-ov108/APGOT-OV29)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Cancer | Fallopian Tube Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| BG-C9074 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: BG-C9074 + Bevacizumab
- description
- BG-C9074 will be administered first, followed by bevacizumab.
- interventionNames
- Drug: BG-C9074
- Drug: Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Bevacizumab
- description
- Bevacizumab will be administered alone.
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression-Free survival (PFS) assessed by Blinded Independent Central Review (BICR)
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available