A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial
Duke University
Summary
This is to study if neoadjuvant atezolizumab therapy is beneficial for patients with recurrent glioblastoma and a low mutational burden.
Description
Recurrent glioblastoma represents one of the highest unmet medical needs in oncology. Overall prognosis remains poor for patients on standard of care therapies, with a 2-year survival rate of \< 20%. Immune checkpoint inhibitors have the potential to meet this unmet medical need, however such therapies have yet to be fully explored in clinical trials powered for efficacy nor in the neoadjuvant setting. The interplay between the immune system and glioblastoma is complex and shaped by a variety of factors. Certain molecular factors that suggest a promising response to immunotherapies, in non-CNS…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years old 2. Pathologically confirmed GBM, IDHwt 3. 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. 4. Tissue available from initial diagnosis of primary GBM 5. Adequate organ function: 1. Hemoglobin ≥ 9 g/dl 2. Platelet count ≥ 75,000/µl 3. Neutrophil count ≥ 1000 cells/mm3 4. Creatinine ≤ 1.5 x ULN (calculated using the Cockcroft…
Interventions
- DrugAtezolizumab
One dose of atezolizumab will be given prior to resection.
Locations (4)
- University of California, San FranciscoSan Francisco, California
- Saint Luke's Cancer InstituteKansas City, Missouri
- Duke UniversityDurham, North Carolina
- Huntsman Cancer InstituteSalt Lake City, Utah