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.
Patients must be ≥4 and ≤25 years of age (inclusive) at the time of study enrollment
Metastatic Disease: Patients with M+ disease are eligible.
ANC (Absolute neutrophil count) ≥ 1000/µl.
Platelets ≥ 75,000/µl.
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.
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Bristol-Myers Squibb
Collaborator
CSBio
Collaborator