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

Running, not enrolling · Phase 1

Conditions studied: Osteosarcoma, Osteosarcoma in Children, Osteosarcoma Recurrent, Sarcoma

In brief

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

Key facts

Study ID

NCT03628209

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

21

Starts

2019-10-03

Expected to finish

2027-04-01

Last updated by the study team

2026-07-30

Who can join

Age: any, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have had a histologic diagnosis of osteosarcoma at original diagnosis
• Disease Status: Patients with an isolated pulmonary recurrence of osteosarcoma can be enrolled on this study.
• Any history of metastatic disease at a site other than lung would make the patient ineligible for this study.
• The patient's treating team must consider the patient's disease to be resectable and the patient must be willing to undergo resection of all disease, including any lung lesion meeting criteria for likely metastatic disease, defined as: 3 or more lesions ≥ 3 mm in diameter OR a single lesion ≥ 5 mm.
• Patients with bilateral disease are eligible provided their disease is considered resectable. Resectable pulmonary nodules are defined as nodules that can be removed without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels).
• Must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2, using the Karnofsky scale for patients > 16 years of age and the Lansky scale for patients ≤ 16 years of age
• Prior Therapy: Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to the start of protocol therapy.
• Participants must have normal organ and marrow function within 7 days of starting protocol therapy
• All participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent/assent document
• Additional criteria may apply

You may not qualify if…

• Pregnancy or Breast Feeding
• Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as outlined in study protocol documentation
• Concomitant Medications: Patients receiving the following are not eligible:
• Corticosteroids or other immunosuppressive medications
• Patients who are currently receiving other investigational agents or other anti-cancer therapy
• Intercurrent Illnesses: Patients with uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Autoimmune disorders: Patients with a history of any Grade autoimmune disorder are not eligible.
• Asymptomatic laboratory abnormalities (e.g., ANA, rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder.
• Patients with ≥ Grade 2 hypothyroidism due to history of autoimmunity are not eligible. Note: Hypothyroidism due to previous irradiation or thyroidectomy will not impact eligibility
• Allergies: Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab (e.g., another humanized antibody) or Azacitidine are not eligible
• Safety and Monitoring: Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible
• Patients with known HIV or hepatitis B or C are excluded
• Patients who have received prior solid organ transplantation are not eligible
• Patients who have received prior anti-PD-1 directed therapy (mAb or small molecule) are not eligible

Where it is running

• 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

Full record on ClinicalTrials.gov

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