NCT05423210 Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
| NCT ID | NCT05423210 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Stony Brook University |
| Condition | Glioblastoma Multiforme |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-10-25 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2022-10-25 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Alexander Stessin, MD
PRINCIPAL INVESTIGATOR
Stony Brook Cancer Center
Frequently Asked Questions
Who can join the NCT05423210 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05423210 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05423210 currently recruiting?
Yes, NCT05423210 is actively recruiting participants. Contact the research team at sumbul.yousafi@stonybrookmedicine.edu for enrollment information.
Where is the NCT05423210 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT05423210 clinical trial?
NCT05423210 is sponsored by Stony Brook University. The principal investigator is Alexander Stessin, MD at Stony Brook Cancer Center. The trial plans to enroll 12 participants.
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