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 (Sep 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: disease-directed therapy including radiotherapy — initial diagnosis of medulloblastoma
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.
Cannot have received: concomitant immunosuppressive agents
Exception: inhaled corticosteroids for asthma are allowed
Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.
Cannot have received: concomitant tumor-directed therapy
Patients receiving concomitant tumor-directed therapy
Cannot have received: other investigational drug therapy
Patients receiving any other investigational drug therapy.
Cannot have received: dexamethasone > 0.1 mg/Kg/day up to maximum dose of 4 mg/day or equivalent (dexamethasone)
Patients on dexamethasone > 0.1 mg/Kg/day up to maximum dose of 4 mg/day or equivalent.
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 as specified
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.
Are there prior therapy exclusions?
Yes. Prior concomitant immunosuppressive agents, concomitant tumor-directed therapy, other investigational drug therapy disqualifies patients from enrollment.
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