Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

NCT05423210 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: SBU-FSRT-NEURO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

• Number of participants who progress/relapse after surgical resection

  Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

  2 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

  30 days after the last dose of atezolizumab

Study Arms (1)

Treatment

EXPERIMENTAL

Combination Product: Atezolizumab + FSRT radiation

Interventions

Atezolizumab + FSRT radiation COMBINATION_PRODUCT

Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of glioblastoma multiforme WHO Grade IV
• The patient is a surgical candidate, with the surgical intent for a \> 80% resection of 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)

You may not qualify if:

• Patient already underwent surgical total or partial tumor resection, or radiation therapy
• 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 per day of systemic dexamethasone
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage 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., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active 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

Sponsors & Collaborators

• Stony Brook University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Alexander Stessin, MD

  Stony Brook Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumbul Yousafi, MS

CONTACT

631-508-2212; sumbul.yousafi@stonybrookmedicine.edu

Alexander Stessin, MD

CONTACT

631-638-1000; alexander.stessin@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: October 25, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)