drugset / Trial / NCT02656706
Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma
Phase 2
Active not recruiting
22 enrolled
Brown University
Rhode Island Hospital · collabThe Miriam Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.
Timeline
- Start
- 2016-07
- Primary completion
- 2019-03
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | — |