A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRetifanlimab
Anti-PD-1 Therapy
- DrugTemozolomide
Anti-PD-1 Therapy
- RadiationRadiation Therapy
Standard of Care
Location
- Johns Hopkins Medical InstitutionBaltimore, Maryland