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NOT YET RECRUITING
NCT06639607
PHASE1/PHASE2

PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

4 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-04-30

Completion Date

2043-04-30

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

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

Locations (3)

Washington University School of Medicine

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States