drugset / Trial / NCT01950390

Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

NCT01950390 ↗

Phase 2 Completed 169 enrolled National Cancer Institute (NCI)
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

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Ipilimumab Monoclonal antibody — Intravenous

Indications