eligibility_summary
Eligible: ≥18, newly diagnosed IDH‑WT, MGMT‑unmethylated WHO grade IV glioma post‑resection with residual enhancement, CMV IgG ±, KPS >70, adequate counts/renal/hepatic function, consent, contraception. Exclude: allergy to gadolinium/TD vaccine, brainstem/cerebellar/spinal/multifocal/leptomeningeal disease or lesions outside RT field post XRT/TMZ, MRI‑ineligible, serious comorbidities/infection/immunosuppression/HIV/HCV, conflicting meds/active cancers, prior non‑SoC CNS therapy/inguinal LN dissection, recent/planned trial, autoimmune (except hypothyroidism/DM).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05283109 tests a peptide cancer vaccine (P30‑EPS) plus Hiltonol (poly‑ICLC). P30‑EPS is a multi‑epitope peptide vaccine: HLA‑A0201–restricted peptides from EphA2, CMV pp65, and survivin, each fused to the tetanus‑toxoid–derived P30 CD4 helper epitope. Type: therapeutic peptide vaccine with an innate immune adjuvant. Mechanisms: P30 provides CD4+ T‑cell help, the peptides prime antigen‑specific CD8+ cytotoxic T cells, Hiltonol (synthetic dsRNA) activates TLR3/MDA5, inducing type I interferon and dendritic cell maturation to enhance Th1/CTL responses. Targets: GBM cells expressing EphA2 (receptor tyrosine kinase) and survivin/BIRC5 (inhibitor of apoptosis), and CMV pp65 antigen, immune pathways include dendritic cells (TLR3/MDA5), CD4+ T helpers, and HLA‑A2–restricted CD8+ T cells. Phase 1b safety/immunogenicity in newly diagnosed MGMT‑unmethylated GBM.