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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05096481 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received radiation therapy.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify