21
Participants
Start Date
October 3, 2019
Primary Completion Date
December 29, 2024
Study Completion Date
December 31, 2025
Nivolumab
Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.
Azacitidine
Phase I Dose Escalation - Dose level 1: NA. Dose level 2: 60 mg/m\^2. Dose level 3: 75 mg/m\^2. Phase II Expansion - Treated at recommended Phase II dose (RP2D).
Post Treatment Surgery
Resection surgery at end of Cycle 1 treatment, day 28-35.
Roswell Park Comprehensive Cancer Center, Buffalo
Alfred I DuPont Hospital for Children, Wilmington
Johns Hopkins University, Sidney Kimmel Cancer Center, Baltimore
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke Health, Durham
Carolina Medical Center, Levine Cancer Institute, Charlotte
Nemours Children's Hospital, Jacksonville
Shand's Hospital for Children at the University of Florida, Gainesville
Nemours Children's Clinic, Orlando
University of Miami - Sylvester Comprehensive Cancer Center, Miami
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center, Tampa
Johns Hopkins All Children's Hospital, St. Petersburg
University of Alabama at Birmingham, Birmingham
Vanderbilt-Ingram Cancer Center, Nashville
University of Kentucky, Markey Cancer Center, Lexington
Nationwide Children's Hospital, Columbus
Cleveland Clinic, Cleveland
University of Texas Southwestern Medical Center, Dallas
University of Texas M.D. Anderson Cancer Center, Houston
Children's Hospital of Colorado, Aurora
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center, Los Angeles
Connecticut Children's Medical Center, Hartford
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER