Clinical trial · Interventional
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab + FSRT radiation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Combination Product: Atezolizumab + FSRT radiation
Primary outcomes (2)
- measure
- Number of participants who progress/relapse after surgical resection
- timeFrame
- 2 years
- description
- Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- 30 days after the last dose of atezolizumab
- description
- Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 medicationReferences
Publications (0)
Data not yet available