Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID05423210

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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