Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma

Conditions

• Diffuse Astrocytoma, IDH-Wildtype
• Recurrent Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample and tumor tissue collection
• Conventional Surgery — PROCEDURE
  Undergo surgery
• Fractionated Stereotactic Radiation Therapy — RADIATION
  Undergo FSRT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Tocilizumab — BIOLOGICAL
  Given IV

Study Details

This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6), which is made by white blood cells and other cells in the body as well as certain types of cancer. This may help lower the body's immune response and reduce inflammation. 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. Fractionated stereotactic radiation therapy uses special equipment to precisely deliver multiple, smaller doses of radiation spread over several treatment sessions to the tumor. The goal of this study is to change a tumor that is unresponsive to cancer therapy into a more responsive one. Therapy with fractionated stereotactic radiotherapy in combination with tocilizumab may suppress the inhibitory effect of immune cells surrounding the tumor and consequently allow an immunotherapy treatment by atezolizumab to activate the immune response against the tumor. Combination therapy with tocilizumab, atezolizumab and fractionated stereotactic radiation therapy may shrink or stabilize the cancer better than radiation therapy alone in patients with recurrent glioblastoma.

Key Dates

First listed

Jan 29, 2021

Start date

Mar 11, 2022

Status verified

Mar 2026

Primary completion

Jun 15, 2025

Completion

Sep 4, 2026

Study Design

Enrollment

61 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Non Surgical Cohort: Arm 1 - Level 1 (tocilizumab)
  The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive tocilizumab 4 mg/kg administered intravenously (IV) over 60 minutes on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) throughout the study.
• Experimental: Non Surgical Cohort: Arm 2 - Level 2 (tocilizumab)
  Patients receive tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Experimental: Non Surgical Cohort: Arm 4 (tocilizumab, atezolizumab)
  The non-surgical cohort is defined as patients with recurrent glioblastoma without a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Experimental: Non Surgical Cohort:Arm 3- Level 3 (tocilizumab, atezolizumab)
  Patients receive atezolizumab administered IV over 30-60 minutes followed by tocilizumab 8 mg/kg IV on Day 1. FSRT timing and fractionation, treatment schedule, and MRI assessments are performed as described in Arm 1. Beginning 4 weeks after the first dose, patients resume atezolizumab plus tocilizumab every 4 weeks in the absence of disease progression or unacceptable toxicity.
• Experimental: Surgical Cohort: Arm A - Neoadjuvant Tocilizumab+Atezolizumab
  The surgical cohort is defined as patients with recurrent glioblastoma with a clinical indication for surgical resection. Patients receive atezolizumab IV followed by tocilizumab 8 mg/kg IV on Day 1. Within 3-7 days, patients undergo FSRT delivered in 3 fractions over 3-5 days, followed by surgical resection 7-14 days after completion of FSRT. Beginning 21-42 days after surgery, patients receive atezolizumab plus tocilizumab every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the study, and blood and tumor tissue are collected on study.
• Experimental: Surgical Cohort: Arm B - Neoadjuvant Atezolizumab Alone
  Patients receive atezolizumab IV alone on Day 1 prior to FSRT and surgery. FSRT timing and fractionation, surgical timing, post operative treatment, MRI assessments, and biospecimen collection are performed as described in Arm A.

Primary Outcome Measure

[Non-surgical Cohort] Maximum-tolerated Dose (Safety Run-In) [ Time Frame: From first dose of study drug through completion of Cycle 1 (28 days). ]

Locations (110)

Related coverage on Hipa.ai

• Atezolizumab trial posts recurrent glioblastoma results
  Atezolizumab · Aug 7, 2026 · ClinicalTrials.gov

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