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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Mayo Clinic- Florida
Jacksonville, Florida, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Assess Recurrence-free survival time (RFS)
Date the patient receives the first dose of study medication to the date of documentation of first disease recurrence or death due to any cause.
Time frame: 1.5 years
Assess the Adverse Events
Adverse events will be graded and attribution assigned using CTCAE version 4
Time frame: 2 years
Overall Survival (OS)
The time from registration to death due to any cause
Time frame: 2 years
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Nebraska Cancer Specialists
Omaha, Nebraska, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States