Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
NCT05083754 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-01-09
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.
Conditions
Interventions
- DRUG
-
Anti-PD-1 Therapy
- DRUG
-
Anti-PD-1 Therapy
- RADIATION
-
Radiation Therapy
Standard of Care
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Lawrence Kleinberg, MD · Johns Hopkins University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-31
- Primary Completion
- 2028-01-31
- Completion
- 2029-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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