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ACTIVE NOT RECRUITING
NCT03628209
PHASE1

Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

DRUG

Nivolumab

Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.

DRUG

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).

PROCEDURE

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