New combo tackles returning bone cancer before surgery

NCT ID NCT03628209

Ongoing Disease control Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-phase trial tests the safety and effectiveness of the immune drug nivolumab (Opdivo) alone or combined with the chemo drug azacitidine (Vidaza) in people whose osteosarcoma has come back and can be surgically removed. About 21 participants will receive the drugs before surgery to see if the combination can help keep the cancer from returning. The study is still in early stages, so the main goals are finding a safe dose and checking how well the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: nivolumab (Opdivo) and azacitidine (Vidaza)
What this could lead to: If successful, this could point toward a new treatment option for recurrent osteosarcoma that may help keep the cancer from coming back after surgery.
What could go wrong: This is a very early, small trial (21 people) focused on safety and finding the right dose. It is not yet known if the combination works better than standard care, and there are risks of side effects from the immune therapy and chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

osteosarcoma pediatric osteosarcoma sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSTEOSARCOMA OSTEOSARCOMA IN CHILDREN OSTEOSARCOMA RECURRENT SARCOMA

Contacts and locations

Locations

Alfred I DuPont Hospital for Children

Wilmington, Delaware, 19803, United States
Carolina Medical Center, Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Children's Hospital of Colorado

Aurora, Colorado, 80045, United States
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center

Los Angeles, California, 90027, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Duke Health

Durham, North Carolina, 27708, United States
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center

Tampa, Florida, 33612, United States
Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States
Johns Hopkins University, Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Nemours Children's Clinic

Orlando, Florida, 32806, United States
Nemours Children's Hospital

Jacksonville, Florida, 32207, United States
Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States
Shand's Hospital for Children at the University of Florida

Gainesville, Florida, 32610, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

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