eligibility_summary
Eligible: adults ≥18 with newly diagnosed primary supratentorial GBM, MGMT-unmethylated, CMV-seropositive, debulking surgery (not biopsy only), completed concurrent RT+TMZ, stable/decreasing steroids, MRI ≤31 days, stable neuro deficits, ECOG 0–2, life expectancy >12 wks, adequate marrow/liver/renal, consent. Exclude: pregnancy, infection/fever, transplant/immunosuppression/autoimmune dz, bevacizumab, HIV/HBV/HCV, severe comorbidity, prior non-RT/TMZ therapy, TMZ intolerance, recent trials/live vaccines, leptomeningeal/multifocal disease, recent cancer, unresolved ≥G2 tox, severe mAb or gadolinium allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I single-arm trial in newly diagnosed MGMT-unmethylated glioblastoma tests PEP-CMV, a long-peptide therapeutic cancer vaccine (26-aa from CMV pp65 with MHC I/II epitopes), given with tetanus-diphtheria (Td) booster/preconditioning and alongside one adjuvant cycle of temozolomide (TMZ). Mechanisms: PEP-CMV induces antigen presentation to expand CMV pp65–specific CD8+ cytotoxic and CD4+ helper T cells that recognize and kill CMV-expressing GBM cells. Td preconditioning activates dendritic cells and provides recall CD4 help, TMZ (alkylating agent) induces lymphopenia to promote homeostatic T-cell expansion. Targets: CMV-positive GBM tumor cells, immune pathways of T-cell activation, antigen presentation (HLA I/II), dendritic cell priming.