Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Early Phase 1

Recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Combination Product: Atezolizumab + FSRT radiation

• Registration Number: NCT05423210
• Lead Sponsor: Stony Brook University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Study Start: 2022-10-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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)

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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 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
• Treatment with systemic immunosuppressive medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Atezolizumab + FSRT radiation	-

Primary Outcome Measures

Name	Time	Method
Number of participants who progress/relapse after surgical resection	2 years	Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	30 days after the last dose of atezolizumab	Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States