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NCT04729959 · ClinicalTrials.gov record · last posted 2026-08-27

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

StatusActive, Not Recruiting
PhasePhase 2
Started2022-03-11
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-08
critical
Primary endpoint(s) modified
WasDose-limiting toxicities (Safety Run-In), Maximum-tolerated dose (Safety Run-In), Objective radiographic response rate (Phase II, Non-Surgical Cohort)
Now[Non-surgical Cohort, Safety Run-In] Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs), [Non-surgical Cohort] Maximum-tolerated Dose (Safety Run-In), [Non-surgical Cohort] Objective Radiographic Response Rate (Phase II)
2026-08-08
minor
Trial arms changed: 3 → 6
Trial Details
NCT Number NCT04729959
Lead Sponsor National Cancer Institute (NCI)
Collaborators: NRG Oncology
Conditions Diffuse Astrocytoma, IDH-Wildtype, Recurrent Glioblastoma
Enrollment 61 participants
Start Date 2022-03-11
Primary Completion 2025-06-15 (estimated)
Study Completion 2026-09-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-27