drugset / Trial / NCT03241186
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma
Phase 2
Active not recruiting
36 enrolled
Robert R. McWilliams, MD
Bristol-Myers Squibb · collabHoosier Cancer Research Network · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.
Timeline
- Start
- 2017-09-12
- Primary completion
- 2022-09-15
- Completion
- 2023-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |