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New combo tackles returning bone cancer before surgery

NCT ID NCT03628209

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 39 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.