NRG-BN010

Closed to Accrual

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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.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.