A Phase 2 Trial of Atezolizumab and Cabozantinib in Adolescents and Young Adults With Recurrent/Metastatic Osteosarcoma (TACOS)
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To assess the efficacy of cabozantinib in combination with atezolizumab in recurrent/metastatic osteosarcoma as determined by the progression-free survival (PFS) defined as the time from treatment onset to either disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first. SECONDARY OBJECTIVES: I. To estimate the objective response rate (ORR) by RECIST 1.1 criteria, immune-based (i)RECIST, and immune-modified (im)RECIST. II. To estimate the progression-free survival (PFS) rates at 4 months and…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Metastatic or unresectable locally advanced disease * Patients must have relapsed or become refractory to conventional therapy including some combination of cisplatin, doxorubicin, methotrexate, and/or ifosfamide * Measurable disease per RECIST version (v)1.1 (Note: Previously irradiated lesions can be considered as measurable disease only if progressive…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugCabozantinib
Given PO
Locations (2)
- Dana-Farber Cancer InstituteBoston, Massachusetts
- M D Anderson Cancer CenterHouston, Texas