OncoMatch/Clinical Trials/NCT05096481
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
Is NCT05096481 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PEP-CMV and Tetanus Diphtheria Vaccine for high grade glioma.
Treatment: PEP-CMV · Temozolomide · Tetanus Diphtheria Vaccine — This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Prior therapy
Must have received: radiation therapy — initial diagnosis of medulloblastoma (unless <4 years old)
Patients must have received prior disease-directed therapy including radiotherapy for their initial diagnosis of medulloblastoma unless patients are less than 4 years of age at the time of enrollment.
Lab requirements
Blood counts
ANC ≥ 1000/µl; Platelets ≥ 100,000/µl (may be supported); Hemoglobin > 8 g/dL (may be supported)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or a serum creatinine based on age/gender
Liver function
Total bilirubin ≤1.5 times institutional ULN; AST(SGOT) ≤3 × institutional upper limit of normal; ALT(SGPT) ≤3 × institutional upper limit of normal
Adequate bone marrow, renal, and liver function as defined in protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Nicklaus Children's Hospital · Miami, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Dana-Farber Cancer Institute · Boston, Massachusetts
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