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About
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
Full description
Treatment will be administered in 28 day cycles with the first cycle in the neoadjuvant setting. This will be followed by surgery to render the participant in surgical remission. Subsequently the participant will continue to receive treatment for up to 12 additional cycles or until recurrence, whichever occurs first. For participants with known bilateral lung recurrence, the nodule[s] in one lung should be resected, prior to the first cycle of chemotherapy.
Enrollment
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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.
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:
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:
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
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Central trial contact
Jessica R Crimella, BSN, RN
Data sourced from clinicaltrials.gov
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