eligibility_summary
Eligible: consent, ECOG 0–1, life expectancy ≥3 mo, histologically confirmed incurable R/M HNSCC of oropharynx/oral cavity/hypopharynx/larynx, HPV status if oropharyngeal, no prior systemic R/M therapy, measurable lesion, PD‑L1 CPS ≥1, adequate organs, contraception, compliance. Exclude: other/unknown primary site, other cancer <5 y, bleeding risk/vessel invasion, CNS mets, symptomatic effusions, prior immunotherapy, recent RT, bleeding/coagulation disorders, serious cardiac disease, recent thromboembolism/TIA/CVA/hypertensive crisis, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 first-line R/M HNSCC (PD‑L1 CPS ≥1). Interventions: AK112 + AK117 vs pembrolizumab + placebo. AK112 (ivonescimab) is a bispecific monoclonal antibody that blocks PD‑1 and neutralizes VEGF‑A, combining T‑cell checkpoint inhibition with anti‑angiogenesis/vascular normalization. AK117 (ligufalimab) is an anti‑CD47 monoclonal antibody that blocks the CD47–SIRPα “don’t‑eat‑me” signal to enhance macrophage phagocytosis and antigen presentation. Control: pembrolizumab, an anti‑PD‑1 monoclonal antibody. Targeted cells/pathways: PD‑1/PD‑L1 axis on T cells/tumor, VEGF‑A/VEGFR signaling in endothelial cells/tumor vasculature, CD47 on tumor cells engaging SIRPα on myeloid cells—aiming to activate both adaptive and innate anti‑tumor immunity.