NCT03241186

Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Robert R. McWilliams, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ipilimumab and Nivolumab Combination Administration * Ipilimumab 1mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles * Nivolumab 3mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles Nivolumab Alone Administration * Nivolumab 480mg given IV Day 1 for 4 weeks (28 days), for 5-15 cycles Nivolumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline. Ipilimumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline or 5% dextrose solution. When both study drugs are to be administered on the same day, separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes after completion of the nivolumab infusion. The dosing calculations should be based on the body weight from Cycle 1 Day 1. If the subject's weight on the day of dosing differs by \> 5% from the weight used to calculate the dose, the dose should be recalculated based on the current day of treatment weight. All doses should be rounded to the nearest milligram. There will be no dose modifications allowed.

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	1mg/kg
DRUG	Nivolumab	3mg/kg
DRUG	Nivolumab	480mg

Timeline

• Start date: 2017-09-12
• Primary completion: 2022-09-15
• Completion: 2023-09-01
• First posted: 2017-08-07
• Last updated: 2022-12-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study