A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

June 11, 2019

Primary Completion Date

July 1, 2023

Study Completion Date

April 7, 2030

Conditions
Melanoma
Interventions
DRUG

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

DRUG

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

DRUG

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

Trial Locations (4)

10016

NYU Langone Health, New York

90025

The Angeles Clinic, Los Angeles

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

All Listed Sponsors
lead

NYU Langone Health

OTHER