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Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 12 wordsv7
  2. Primary completion date: Aug 2026 to Aug 2027
    • Study completion date: Aug 2026 to Aug 2029
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Sep 21, 2022 to Oct 25, 2022
    • Site details revised
    v4
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 31, 2022 to Sep 21, 2022
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Stony Brook University
44 trials monitored
See 1 trial at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
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.
Trial Details
NCT Number NCT05423210
Lead Sponsor Stony Brook University
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Glioblastoma Multiforme
Related terms Glioblastoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov