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New treatment option for Glioblastoma Multiforme
Official title Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
ClinicalTrials.gov ID: NCT05423210
What this study is testing
What is Atezolizumab + FSRT radiation?
Atezolizumab + FSRT radiation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.