Clinical Research Directory
Browse clinical research sites, groups, and studies.
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab in combination with azacitidine in participants with recurrent, resectable osteosarcoma
Official title: A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Key Details
Gender
All
Age Range
Any - 39 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2019-10-03
Completion Date
2026-04
Last Updated
2026-02-05
Healthy Volunteers
No
Interventions
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.
Locations (22)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Alfred I DuPont Hospital for Children
Wilmington, Delaware, United States
Shand's Hospital for Children at the University of Florida
Gainesville, Florida, United States
Nemours Children's Hospital
Jacksonville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center
Tampa, Florida, United States
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Johns Hopkins University, Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolina Medical Center, Levine Cancer Institute
Charlotte, North Carolina, United States
Duke Health
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States