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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2023
  • participants needed
    51
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 5 June 2022
metastatic disease
azacitidine
metastasis
cancer chemotherapy
resectable osteosarcoma

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

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.

Details
Condition Osteosarcoma, Osteosarcoma in Children, Osteosarcoma Recurrent, Sarcoma
Treatment Nivolumab, Azacitidine, Post Treatment Surgery
Clinical Study IdentifierNCT03628209
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
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
(ECOG) scores of 0, 1 or 2, using the Karnofsky scale for patients > 16 years
Participants must have normal organ and marrow function within 7 days of starting protocol therapy
of age and the Lansky scale for patients ≤ 16 years of age
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
Intercurrent Illnesses: Patients with uncontrolled intercurrent illness including, but not limited to
Patients who are currently receiving other investigational agents or other anti-cancer
Ongoing or active infection
therapy
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
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
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
Autoimmune disorders: Patients with a history of any Grade autoimmune disorder are not
Safety and Monitoring: Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible
eligible
Patients with known HIV or hepatitis B or C are excluded
Patients who have received prior solid organ transplantation are not eligible
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
Patients who have received prior anti-PD-1 directed therapy (mAb or small molecule) are not eligible
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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