drugset / Trial / NCT01950390
Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial studies how well ipilimumab with or without bevacizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ipilimumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Timeline
- Start
- 2014-01-24
- Primary completion
- 2021-10-06
- Completion
- 2025-01-31
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A (Ipilimumab) vs Arm B (Ipilimumab and Bevacizumab); p = 0.383; Hazard Ratio (HR) 0.94; Log Rank; note: One-sided NCT01950390 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | — | Intravenous |