71
Participants
Start Date
June 11, 2019
Primary Completion Date
July 1, 2023
Study Completion Date
April 7, 2030
Ipilimumab
4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
Nivolumab
Nivolumab (3 mg/kg) will be administered IV on Days 1 and 22 of each 42-day induction treatment cycle. Nivolumab will continue to be administered IV at 240 mg flat dose every 2 weeks; i.e., at Days 1, 15, 29, 43, 57, and 71 of the 84-day treatment cycle for the first maintenance cycle until week 24, then nivolumab will be administered at 480 mg flat dose every 4 weeks to a maximum of 2 years
Tocilizumab
Administered intravenously for each 42-day induction treatment cycle. After 12 weeks of therapy, starting at Week 13, subjects enter the maintenance phase. Tocilizumab will be administered intravenously every 6 weeks during the first 84 day maintenance treatment cycle only at 4 mg/kg
NYU Langone Health, New York
The Angeles Clinic, Los Angeles
Massachusetts General Hospital, Boston
Dana Farber Cancer Institute, Boston
NYU Langone Health
OTHER