eligibility_summary
Inclusion: Adults 18–65 with newly diagnosed p16/HPV16+ oropharyngeal SCC, locoregionally advanced (T2N2–3, T3N0–3, or T4N0–3, M0), tumor accessible for biopsy/intratumoral dosing, no distant mets (HPV16+ secondaries allowed), KPS 70–100/ECOG 0–1, life ≥6 mo, acceptable ECG, WOCBP negative test + contraception, consent. Exclusion: mets, other active cancer, major lab/organ/cardiac disease, recent vax/infections, HBV/HCV/HIV, autoimmune disease, immunosuppression/steroids, recent surgery, pregnancy/breastfeeding, other trials, Tamiflu allergy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm study in HPV16+ oropharyngeal SCC. Intervention: FluBHPVE6E7, a biological, live-attenuated influenza B delNS viral vector vaccine encoding HPV16 E6/E7, given intratumorally first, then intramuscularly. Mechanism of action: The NS deletion heightens innate sensing (RIG-I/TLR) and type I interferon, enhancing dendritic cell activation and antigen presentation. Vector-driven E6/E7 expression primes robust HPV16 E6/E7–specific CD8+ and CD4+ T-cell responses, promoting MHC I–restricted tumor cell killing and in situ vaccine effects. Cells/paths targeted: HPV16 E6/E7–expressing tumor cells, dendritic cells/APCs, cytotoxic T lymphocytes. Key pathways: interferon signaling, antigen presentation (MHC I/II), T-cell cytotoxicity (perforin/granzyme), and Th1-polarized immunity.