Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma (rGBM)
M.D. Anderson Cancer Center
Summary
This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). 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 control the disease in patients with recurrent glioblastoma.
Description
PRIMARY OBJECTIVES: I. To evaluate the safety of atezolizumab in combination with cabozantinib. (Phase I) II. To evaluate the progression-free survival at six months (PFS-6) of atezolizumab in combination with cabozantinib. (Phase II) SECONDARY OBJECTIVE: I. To evaluate the progression free survival (PFS), overall survival (OS), overall response rate (ORR) and duration of response of atezolizumab in combination with cabozantinib. CORRELATIVE OBJECTIVES: I. Profiling tumor immune cell populations (i.e., macrophage migration inhibitory factor \[mIF\] and immunohistochemistry \[IHC\] analyse…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent form (ICF) * Ability and willingness to comply with the requirements of the study protocol * Age \>= 18 years * Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). Archival tissue will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment * Patients must have been previously treated with radiation and temozolomide * Patients must be at least 12 weeks out from completion of concurrent chemoradiation * Have a performance status of \>= 60 on the…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugCabozantinib
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas