Recruiting
Early Phase 1

Atezolizumab & Radiation

Sponsor:

Stony Brook University

Code:

NCT05423210

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atezolizumab + FSRT radiation

Study Details

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.

Conditions

Glioblastoma Multiforme

Study ID

NCT05423210

Start date

Oct 25, 2022

Status verified date

Dec, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Interventions

Atezolizumab + FSRT radiation

Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Primary outcome measure

  • Number of participants who progress/relapse after surgical resection [ Time Frame: 2 years ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 30 days after the last dose of atezolizumab ]

Central Contacts and Locations

Central contacts

Sumbul Yousafi, MS

631-508-2212sumbul.yousafi@stonybrookmedicine.edu

Alexander Stessin, MD

631-638-1000alexander.stessin@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Alexander M Stessin, MD

631-444-2200alexander.stessin@stonybrookmedicine.edu

Caterina Vacchi-Suzzi, PhD

631-216-2993caterina.vacchi-suzzi@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2025-12-22.