Phase 1/2 Trial of PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma (PRiME II)
Washington University School of Medicine
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.
Eligibility
- Age range
- 4–25 years
- Sex
- All
- Healthy volunteers
- No
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 Sc…
Interventions
- BiologicalPEP-CMV vaccine
Intra-dermally administered half in the RIGHT groin and half in the LEFT groin.
- BiologicalTetanus booster
Td 5 flocculation units, Lf
- BiologicalNivolumab
Administered intravenously
- DrugTemozolomide
Administered orally
Locations (3)
- Washington University School of MedicineSt Louis, Missouri
- Duke University Medical CenterDurham, North Carolina
- MD Anderson Cancer CenterHouston, Texas