Adjuvant Nivolumab and Low Dose Ipilimumab for Stage III and Resected Stage IV Melanoma: A Phase II Brown University Oncology Research Group Trial

NCT02656706 Phase 2 ACTIVE_NOT_RECRUITING Results posted

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.

Details

Lead sponsor	Brown University
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	22
Start date	2016-07
Completion	2026-06

Conditions

• Melanoma

Interventions

• Ipilumumab
• Nivolumab

Primary outcomes

• Number of Participants With Treatment Related Toxicities — From day 1 of treatment through 30 days post the last dose of drug, for a total of about 7 months.
• Number of Participants With Progression-free and Survival Overall — Post treatment for up to 5 years

Countries

United States