eligibility_summary
Inclusion: ≥18, HPV16+ PD‑L1 CPS≥1 R/M oropharyngeal HNSCC not curable locally, pembro‑eligible, ECOG 0–1, measurable disease, adequate organs (eGFR≥45), contraception/consent. Exclusion: non‑oropharynx, prior systemic Rx in R/M (incl ICIs), recent RT/surgery/live vaccines, transplant/CAR‑T, immunosuppression or chronic steroids, bleeding disorder, major cardiac dz/MI, pneumonitis/ILD, active infection incl HIV/HBV/HCV, active CNS mets, allergy to study drugs/aminoglycosides, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: VB10.16—an investigational therapeutic DNA vaccine (plasmid immunotherapy) encoding HPV16 E6/E7—given intramuscularly to target antigen-presenting cells and elicit strong HPV16-specific T‑cell responses, Pembrolizumab—an anti–PD‑1 immune checkpoint inhibitor (humanized IgG4 monoclonal antibody). Target cells/pathways: VB10.16 engages dendritic cell antigen presentation to prime/expand CD8+ cytotoxic and CD4+ helper T cells against HPV16+ tumor cells, Pembrolizumab blocks the PD‑1/PD‑L1 axis on T cells/tumor, releasing T‑cell inhibition to enhance antitumor killing.