Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Trial Parameters
Brief Summary
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.
Eligibility Criteria
Inclusion Criteria: * Newly-diagnosed adults with WHO (World Health Organization) Grade IV Glioblastoma or gliosarcoma based on histopathological or molecular criteria who had carmustine wafers placed at resection * No prior treatment for GBM other than surgical resection and carmustine wafer placement (Patients who had a biopsy prior to resection are allowed) * Post-operative MRI or CT scan within 72 hours (preferably 24 hours) of surgical resection * Substantial recovery from surgical resection * On a stable or decreasing dose of steroids * Karnofsky Performance Status of ≥ 60 * Clinically appropriate for concomitant temozolomide plus radiation therapy (RT) based on institutional guidelines * Age ≥18 years * Ensure that pregnant or lactating females are not enrolled and that contraceptive requirements are in accordance with applicable and recent requirements. * Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening thro