PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Di… (NCT06639607) | Clinical Trial Compass
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 2026-06-30
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 range
4 Years – 25 Years
Sex
ALL
See this in plain English?
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 6 months after completion of study participation. Pregnancy tests must be obtained in girls and women who are post-menarchal at screening, at least 24 hours prior to the first dose of nivolumab and every 4 weeks (+/- 1 week) regardless of dosing schedule. An extension up to 72 hours prior to t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)