Actively Recruiting
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
Led by Stony Brook University · Updated on 2025-12-22
12
Participants Needed
1
Research Sites
353 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
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
Official 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
- Candidate for surgery aiming for more than 80% tumor removal
- Negative pregnancy test
- ECOG performance status of 2 or less
- Tumor volume 3.5 cm or less
- Adequate organ function
- Negative for infections including HIV, Hepatitis B, Hepatitis C, and tuberculosis
You will not qualify if you...
- Previous surgical tumor removal or radiation therapy
- Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, or bilateral cerebral hemisphere involvement
- Increased risk of neurological decline
- Use of high dose intravenous or oral corticosteroids over 8 mg/day dexamethasone
- Uncontrolled tumor-related pain
- Uncontrolled fluid buildup requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- History of autoimmune disease or immune deficiency
- History of certain lung diseases or active pneumonitis
- Significant cardiovascular disease
- Other malignancy within 1 year before screening
- Severe infection within 4 weeks before study treatment
- History of stem cell or organ transplant
- Prior treatment with CD137 agonists or immune checkpoint inhibitors
- Treatment with systemic immunostimulatory or immunosuppressive medications
AI-Screening
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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
CONTACT
A
Alexander Stessin, MD
CONTACT
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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