This phase II trial studies the effect of atezolizumab and cabozantinib in treating adolescents and young adults with osteosarcoma that has come back (recurrent) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help to control the osteosarcoma.
Signed informed consent form
Age >= 12 years at time of signing informed consent form
Ability to comply with the study protocol, in the investigator's judgment
Histologically confirmed diagnosis of osteosarcoma
Inability to swallow tablets
Prior treatment with cabozantinib
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies if given in combination with a VEGF-targeted tyrosine kinase inhibitor (TKI). Patients receiving prior anti-PD-1, anti-PD-L1, with or without anti-CTLA-4 antibodies will not be excluded
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment
Single group
Atezolizumab
Biological/VaccineGiven IV
Cabozantinib
DrugGiven PO
Progression-free survival (PFS)
Defined by Response Evaluation Criteria in Solid Tumors (RECIST). Will estimate the PFS using the Kaplan-Meier method.
Objective response rate
Estimated by RECIST 1.1 criteria, immune-based RECIST, and immune-modified RECIST.
PFS
Will be estimated along with a 95% confidence interval. Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups. Regression analyses of survival data based on the Cox proportional hazards model will be conducted on PFS. The proportional hazards assumption will be evaluated graphically and analytically, and regression diagnostics (e.g., martingale and Shoenfeld residuals) will be examined to ensure that the models are appropriate.
Overall survival (OS)
Will be estimated along with a 95% confidence interval. Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups. Regression analyses of survival data based on the Cox proportional hazards model will be conducted on OS. The proportional hazards assumption will be evaluated graphically and analytically, and regression diagnostics (e.g., martingale and Shoenfeld residuals) will be examined to ensure that the models are appropriate.
Incidence of adverse events
Common Terminology Criteria for Adverse Events version 5.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. Toxicity rate will be estimated with 95% credible interval.
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