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
Principal Investigator
Stephen Bagley, MD, MSCE
Status
Closed to Accrual
Date Opened To Accrual
July 06 2021
Date Closed to Accrual
November 14 2024
Disease Site
Brain [BN]
Other
Phase
I/II
Developmental Therapeutics
Yes
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)
Patient Population
Glioblastoma that is in first recurrence following prior first-line radiation therapy
Target Accrual
53
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.