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Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT04729959
Phase: Phase I/II
Principal Investigator: Vogelbaum, Michael
A Safety Run-In and Phase II Study Evaluating the Efficacy, Safety, and Impact on the Tumor Microenvironment of the Combination of Tocilizumab, Atezolizumab, and Fractionated Stereotactic Radiotherapy in Recurrent Glioblastoma
Primary Objective: * Safety Run-In: To determine the maximum-tolerated dose (MTD) among three sequential dose levels: single-agent tocilizumab 4mg/kg, single-agent tocilizumab 8mg/kg, and tocilizumab 8mg/kg + atezolizumab 1680mg (each administered with FSRT), to be used for subsequent phase II testing * Phase II (non-surgical cohort): To determine the efficacy of the combination of tocilizumab (anti-IL6R), atezolizumab (anti-PD-L1), and FSRT in recurrent GBM, as measured by the objective radiographic response rate (ORR) Secondary Objectives: * To estimate the progression-free survival (PFS) in patients with recurrent GBM treated with the combination of tocilizumab (anti-IL6R) and FSRT (and atezolizumab (anti-PD-L1), if Dose Level 3 is MTD) (phase II non-surgical cohort and safety run-in cohort) * To estimate the overall survival (OS) in patients with recurrent GBM treated with the combination of tocilizumab (anti-IL6R) and FSRT (and atezolizumab (anti-PD-L1), if Dose Level 3 if the MTD) (phase II non-surgical cohort and safety run-in cohort) * To estimate the progression-free survival (PFS) in patients with recurrent GBM treated with the combination of tocilizumab (anti-IL6R), atezolizumab (anti-PD-L1), and FSRT (phase II surgical cohort) * To estimate the overall survival (OS) in patients with recurrent GBM treated with the combination of tocilizumab (anti-IL6R), atezolizumab (anti-PD-L1), and FSRT (phase II surgical cohort) * To determine the rate and severity of AEs of the combination of tocilizumab (anti-IL6R), atezolizumab (anti-PD-L1), and FSRT in recurrent glioblastoma according to CTCAE v 5.0 (separately in the nonsurgical and surgical cohorts)
Immunotherapy; Radiotherapy
Atezolizumab (Tecentriq); Radiotherapy (); Tocilizumab ()
Inclusion Criteria:
Exclusion Criteria:
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