Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

Mucosal Melanoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Melanoma
• Mucosal Melanoma

• NCT number: NCT03241186
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 12, 2017
• Completion date: September 2023