eligibility_summary
Adults ≥18, ECOG 0–1 with untreated recurrent/metastatic p16+ (hrHPV+) PD-L1 CPS≥1 oropharyngeal cancer, eligible for pembrolizumab, with evaluable disease and adequate organ function. Key excludes: curable disease, non-OPC/multiple primaries, prior R/M therapy, pregnancy/breastfeeding, recent live vaccine/investigational therapy, CNS mets, immunodeficiency or active HIV/HBV/HCV/autoimmune disease, transplants, severe cardiac/ILD/pneumonitis, immunosuppression, pembrolizumab allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05799144: Phase II, single-arm study of a heterologous prime–boost HPV immunotherapy plus checkpoint blockade in PD‑L1 CPS≥1, hrHPV+ recurrent/metastatic oropharyngeal cancer. Interventions: pBI‑11 (plasmid DNA vaccine) and TA‑HPV (recombinant vaccinia viral vector vaccine) designed to present HPV16/18 tumor antigens and elicit antibody and cytotoxic T‑cell responses, combined with pembrolizumab (anti‑PD‑1 monoclonal antibody checkpoint inhibitor). Targets: HPV E6/E7 antigen–expressing tumor cells, dendritic cell–mediated antigen presentation, activation of HPV‑specific CD8+ and CD4+ T cells and B‑cell responses, and the PD‑1/PD‑L1 inhibitory pathway to reverse T‑cell exhaustion and enhance tumor killing.