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NCT Number: NCT05423210

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab + FSRT radiation

Combination Product

Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Primary outcomes

  1. Number of participants who progress/relapse after surgical resection

    Time frame: 2 years

    Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 30 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Stessin, MD

CONTACT

[email protected]

631-638-1000

Sumbul Yousafi, MS

CONTACT

[email protected]

631-508-2212

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Jun 21, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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