Actively Recruiting
A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)
Led by Stony Brook University · Updated on 2025-12-22
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Stony Brook University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with newly diagnosed Glioblastoma Multiforme, a malignant brain tumor with a poor outlook. This early phase 1 pilot study aims to evaluate the immune effects of combining fractionated stereotactic radiotherapy (FSRT) with Atezolizumab (Tecentriq), an FDA-approved PD-L1 inhibitor drug. The study is led by Stony Brook University and focuses on how this combination may affect tumor progression and treatment safety. Participants will receive FSRT for 2 weeks along with two doses of Atezolizumab 840 mg intravenous (IV), one at the start and one at the end of the radiotherapy period. After this initial treatment, patients will have surgery to remove as much of the tumor as safely possible, following standard care. Post-surgery, patients will continue with normal glioblastoma care and receive Atezolizumab 840 mg IV every 2 weeks during the adjuvant treatment phase. During the study, participants will be closely monitored for tumor progression or relapse over 2 years after surgery and for treatment-related side effects within 30 days after the last Atezolizumab dose using standard criteria. Assessments will include clinical evaluations and safety monitoring. The total duration of involvement covers initial treatment, surgery, adjuvant therapy, and follow-up to assess outcomes and adverse events.
CONDITIONS
Brief Title
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of glioblastoma multiforme WHO Grade IV
- Patient is a surgical candidate with intent for > 80% tumor resection
- Negative pregnancy test
- ECOG status of 2 or less
- Tumor volume 3.5 cm or less
- Adequate organ function
- Negative for infectious diseases including HIV, Hepatitis B, Hepatitis C, and tuberculosis
You will not qualify if you...
- Previous surgical tumor resection or radiation therapy
- Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, or bilateral cerebral hemisphere involvement
- Increased risk of neurologic decompensation
- Continued use of high dose intravenous or oral corticosteroids above 8 mg/day dexamethasone
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- History of autoimmune disease or immune deficiency
- History or evidence of active pneumonitis or related lung diseases
- Significant cardiovascular disease
- Other malignancy within 1 year prior to screening
- Severe infection within 4 weeks before treatment
- History of allogeneic stem cell or organ transplant
- Prior treatment with CD137 agonists or immune checkpoint therapies
- Treatment with systemic immunostimulatory or immunosuppressive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the time of surgical resection, approximately several weeks
Participants receive atezolizumab intravenously every 2 weeks combined with fractionated stereotactic radiotherapy before surgery.
Multiple visits every 2 weeks for atezolizumab and radiation sessions
Trial Site Locations
Total: 1 location
1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
Research Team
S
Sumbul Yousafi, MS
A
Alexander Stessin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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