PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Di… (NCT06639607) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
United States68 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range4 Years – 25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for All Patients:
* Patients must be ≥4 and ≤25 years of age (inclusive) at the time of study enrollment
* Metastatic Disease: Patients with M+ disease are eligible.
* Adequate bone marrow function defined as:
* ANC (Absolute neutrophil count) ≥ 1000/µl.
* Platelets ≥ 75,000/µl.
* Hemoglobin \> 8 g/dL. (may be supported)
* Adequate renal function defined as:
* Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m\^2 OR A serum creatinine based on age/gender as listed in the protocol. Note: The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
* Adequate liver function defined as:
* Total bilirubin ≤1.5 times institutional ULN
* AST(SGOT) ≤3 × institutional upper limit of normal
* ALT(SGPT) ≤3 × institutional upper limit of normal
* The effects of PEP-CMV and nivolumab on the developing human fetus are unknown. For this reason, female participants of childbearing potential and male participants who are sexually active must agree to use adequate contraception prior to study entry, for the duration of study participation, and for at least 5 months after completion of study participation. Should a female participant become pregnant or suspect she is pregnant while participating in this study, or should a male participant suspect he has fathered a child, s/he must inform the treating physician immediately.
* Ability to understand…
What they're measuring
1
Proportion of patients with unacceptable toxicity
Timeframe: From the first vaccine (day 21) through 2 weeks after the third vaccine (day 49) (estimated to be 42 days)