RecruitingDiffuse Midline GliomaDiffuse Midline High-grade GliomaMedulloblastoma
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
Eligible age
4–25 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls and women who are post-menarchal at least 7 days prior to study enrollment. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- ✕ Active infection requiring treatment.
- ✕ Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history
- ✕ Known immunosuppressive disease.
- ✕ Patients with active unrelated systemic illness including but not limited to renal, hepatic cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen, medications) and/or limiting activities of daily living (generally CTCAE Grade 2 or higher) or shortness of breath with limited exertion are not eligible. Pulmonary conditions include (but are not limited to) COPD, asthma, and hemi-pneumectomy
- ✕ Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.
- ✕ Patients receiving concomitant tumor-directed therapy.
- ✕ Patients receiving any other investigational drug therapy.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06639607 · last updated 2026-06-17