Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Last updated: June 19, 2025
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

1

Condition

Gliomas

Astrocytoma

Glioblastoma Multiforme

Treatment

Atezolizumab + FSRT radiation

Clinical Study ID

NCT05423210
SBU-FSRT-NEURO
  • Ages > 18
  • All Genders

Study Summary

This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of glioblastoma multiforme WHO Grade IV

  • The patient is a surgical candidate, with the surgical intent for a > 80% resectionof the lesion

  • Negative pregnancy test

  • ECOG status <= 2

  • Tumor volume <= 3.5 cm

  • Adequate organ function

  • Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus,Hepatitis C Virus, tubercolosis)

Exclusion

Exclusion Criteria:

  • Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease,bilateral cerebral hemisphere involvement ("butterfly" gliomas)

  • Patients at increased risk of neurologic decompensation

  • Continued use of high dose intravenous or oral corticosteroids, or > 8milligrams perday of systemic dexamethasone

  • Uncontrolled tumor-related pain

  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrentdrainage procedures (once monthly or more frequently)

  • Uncontrolled or symptomatic hypercalcemia

  • History of autoimmune disease or immune deficiency

  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitisobliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence ofactive pneumonitis

  • Significant cardiovascular disease

  • History of other malignancy within 1 year prior to screening

  • Severe infection within 4 weeks prior to initiation of study treatment

  • History of allogeneic stem cell or organ transplant

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies

  • Treatment with systemic immunostimulatory agents

  • Treatment with systemic immunosuppressive medication

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Atezolizumab + FSRT radiation
Phase: 1
Study Start date:
October 25, 2022
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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