TrialBridgeNCT05083754
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Recruiting · Phase 1 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · registry updated 2026-01-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
Exclusion
- Recurrent glioblastoma (GBM) or progression of lower grade tumor
- Central nervous system (CNS) hemorrhage of Grade \> 1 on baseline MRI scan, unless subsequently documented to have resolved
- Any known metastatic extracranial or leptomeningeal disease
- Intent to use other anti-neoplastic medications/treatments including the Optune® device
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways