drugset / Trial / NCT06639607
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
Phase 1/2
Suspended
68 enrolled
Washington University School of Medicine
Bristol-Myers Squibb · collabCSBio · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multisite, phase I/II clinical trial in children and young adults with newly-diagnosed high-grade glioma (HGG), diffuse midline glioma (DMG) and recurrent HGG/DMG, Medulloblastoma (MB), or ependymoma (EPN) to determine the safety, immunogenicity, and efficacy of a CMV-directed peptide vaccine plus checkpoint blockade.
Timeline
- Start
- 2026-08-31
- Primary completion
- 2031-08-31
- Completion
- 2051-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | PEP-CMV | Vaccine | 250 ug/m2 | Other |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |
| Background | Tetanus booster | Vaccine | 5 unknown | — |