This is to study if neoadjuvant atezolizumab therapy is beneficial for patients with recurrent glioblastoma and a low mutational burden.
Age ≥ 18 years old
Pathologically confirmed GBM, IDHwt
Clinical or radiologic evidence of first or second recurrence following radiation and TMZ. Note: A diagnostic biopsy is required prior to the commencement of the study drug if there is uncertainty about the MRI findings being true progression versus pseudoprogression.
Tissue available from initial diagnosis of primary GBM
Pregnancy or breastfeeding or intention of becoming pregnant during study treatment or within 5 months of final dose of atezolizumab therapy
Prior treatment with immunotherapy
Prior treatment with bevacizumab within 4 weeks before biopsy. Note: Bevacizumab will be permitted if necessary to control inflammatory side effects 5-7mg/kg Q 3/52 for up to 3 cycles
Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.
Single group
Atezolizumab
DrugOne dose of atezolizumab will be given prior to resection.
Median survival within the low and high TMB groups
Survival of the prospectively treated patient is defined as the time between initiation of atezolizumab and death. If the patient is alive at the time of analysis, survival will be censored at the time of last follow-up.
Median survival within the low and high TMB groups and their respective matched historical control group
For comparisons between prospectively treated patients and their matched historical control groups, OS for prospectively treated patients will be measured from the date of atezolizumab until death or last contact. Survival for the matched group is defined as the time between the date of 1st recurrence and death or last contact.
Proportion of patients that experience grade 3, 4, or 5 adverse events that are possibly, probably, or definitely related to atezolizumab.
Describe the safety of neoadjuvant atezolizumab in patients diagnosed with recurrent WHO grade 4 GBM, IDHwt between low vs high TMB arms
Compare Progression Free Survival (PFS) using mRANO criteria between low vs high TMB arms and between TMB-matched historical control arms (low and high TMB)
For patients who are prospectively treated with atezolizumab, PFS is defined as the time between initiation of atezolizumab and initial failure (death, or disease progression). If the patient is alive without disease progression at the time of analysis, PFS will be censored at the time of last follow-up. For patients within the matched historical control group, PFS is defined as the time between 1st recurrence and subsequent failure (death or disease progression). If the historical control patient is alive without disease progression at the time of analysis, PFS will be censored at the time of last follow-up.
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