Tocilizumab + Atezolizumab + Radiation Therapy for Glioblastoma

Recruiting at 117 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of tocilizumab, atezolizumab, and precise radiation therapy in patients with recurrent glioblastoma. Tocilizumab reduces inflammation, atezolizumab boosts the immune system, and the radiation targets the tumor. The goal is to make the tumor more responsive to treatment and improve patient outcomes.

Research Team

Stephen J Bagley

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with recurrent glioblastoma, a type of brain cancer, who've had prior radiation therapy. They must have adequate organ function and not be pregnant or nursing. Participants need to agree to use contraception and can't have certain infections, autoimmune diseases, or recent treatments that could affect the immune system.

Inclusion Criteria

Specific intervals from previous treatments to registration are required to be eligible

I am 18 years old or older.

I have been diagnosed with glioblastoma.

Exclusion Criteria

My tumor has a mutation in the IDH1 or IDH2 gene.

I have a genetic defect in DNA repair.

I have a significant liver condition.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Fractionated Stereotactic Radiation Therapy (Radiation)
• Tocilizumab (Monoclonal Antibodies)

Trial Overview The study tests if adding tocilizumab (an antibody targeting inflammation) and atezolizumab (an immunotherapy drug) to fractionated stereotactic radiation therapy is more effective in treating recurrent glioblastoma than radiation alone.

Participant Groups

Group I: Group II, Arm II (tocilizumab, atezolizumab, FSRT, surgery) Experimental Treatment 6 Interventions

Patients receive systemic treatment with atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3-5 fractions over 3-5 days. Within 7-14 days after FSRT, patients undergo surgery. Within 21-24 days from the first dose of systemic treatment, patients resume treatment with tocilizumab IV over 60 minutes with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and tumor tissue collection on study. Patients undergo MRI throughout the trial, as well as blood sample and tumor tissue collection on study.

Group II: Group II, Arm I (tocilizumab, atezolizumab, FSRT, surgery) Experimental Treatment 6 Interventions

Patients receive systemic treatment with tocilizumab IV over 60 minutes with or without atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3 fractions over 3-5 days. Within 7-14 days after FSRT, patients undergo surgery. Within 21-24 days from the first dose of systemic treatment, patients resume treatment with tocilizumab with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial, as well as blood sample and tumor tissue collection on study.

Group III: Group I (tocilizumab, atezolizumab, FSRT) Experimental Treatment 4 Interventions

Patients receive systemic treatment with tocilizumab IV over 60 minutes with or without atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Starting 4 weeks from the first dose of systemic treatment, patients resume treatment with tocilizumab with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+