Atezolizumab and Radiation for Glioblastoma Multiforme

This study is testing a new approach for people with newly diagnosed glioblastoma multiforme, a type of aggressive brain tumor. It combines a drug called Atezolizumab (Tecentriq), which works by blocking a protein called PD-L1 to help your immune system fight cancer, with radiation therapy (FSRT). You would receive Atezolizumab and radiation for two weeks before surgery to remove the tumor. After surgery, you would continue to receive Atezolizumab along with standard care. The study aims to see how many participants' tumors grow back or worsen after surgery within two years, and to track any side effects from the treatment within 30 days of the last Atezolizumab dose. To join, you must have newly diagnosed glioblastoma, be able to have surgery, and meet other health requirements. The study is currently unclear on its recruitment status.

Study design
This is a small, single-group study involving 12 participants. Everyone in the study will receive the same treatment.
What's involved
You would receive Atezolizumab and radiation for two weeks before surgery. After surgery, you would continue Atezolizumab every two weeks during your adjuvant treatment.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track how many participants' tumors grow back or worsen for up to two years after surgery. They will also monitor for side effects for 30 days after your last dose of Atezolizumab.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05423210

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Stony Brook University
~12 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Atezolizumab + FSRT radiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who progress/relapse after surgical resection
Measured over 2 years
+1 more outcome measured
Glioblastoma Multiforme
1 sites across 1 states
New York1
  • Alexander Stessin, MD · PRINCIPAL_INVESTIGATOR · Stony Brook Cancer Center

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Eligibility criteria

Inclusion

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)

Exclusion

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
Treatment with systemic immunosuppressive medication
  • Number of participants who progress/relapse after surgical resection2 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 v5.030 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