NRG-BN010
Closed to Accrual
Protocol Information
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
Status
Closed to Accrual
Open to Accrual
July 6, 2021
Temporarily Closed to Accrual
June 29, 2022
Open to Accrual
September 26, 2022
Temporarily Closed to Accrual
December 2, 2022
Open to Accrual
January 20, 2023
Temporarily Closed to Accrual
January 30, 2023
Open to Accrual
April 10, 2023
Temporarily Closed to Accrual
April 17, 2023
Open to Accrual
June 27, 2023
Temporarily Closed to Accrual
July 20, 2023
Open to Accrual
July 31, 2023
Temporarily Closed to Accrual
August 8, 2023
Open to Accrual
February 1, 2024
Closed to Accrual
November 14, 2024
Disease Site
Brain [BN] Other
Phase
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
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.