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 Trial of PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma (PRiME II)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Midline Glioma
• Diffuse Midline High-grade Glioma
• Medulloblastoma
• Ependymoma

Interventions

Type	Name	Description
BIOLOGICAL	PEP-CMV vaccine	Intra-dermally administered half in the RIGHT groin and half in the LEFT groin.
BIOLOGICAL	Tetanus booster	Td 5 flocculation units, Lf
BIOLOGICAL	Nivolumab	Administered intravenously
DRUG	Temozolomide	Administered orally

Timeline

• Start date: 2026-04-30
• Primary completion: 2031-06-30
• Completion: 2043-04-30
• First posted: 2024-10-15
• Last updated: 2026-03-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study