eligibility_summary
Adults ≥18 with resectable, non-bulky HNSCC (usually T1N1–N2b or T2–4N0–N2b, tumor board may allow other low-volume cases), ECOG 0–1, candidates for curative surgery, adequate organ function, consent and baseline/on-treatment biopsies, contraception, not pregnant. Exclude prior PD‑1/PD‑L1, recent systemic therapy/RT or investigational use, live vax <30d, immunodeficiency/high steroids, active CNS mets, severe allergy, autoimmune, ILD, infection, HIV/HBV/HCV, major cardiac disease, allogeneic transplant, or other confounders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm neoadjuvant/adjuvant immunotherapy trial in resectable head and neck squamous cell carcinoma testing: 1) Pembrolizumab—type: monoclonal antibody (IgG4) immune checkpoint inhibitor, mechanism: blocks PD-1 on T cells to prevent PD-L1/PD-L2–mediated inhibitory signaling, restoring cytotoxic T-cell activity. 2) IO102-103—type: subcutaneous therapeutic peptide vaccine, mechanism: long peptides derived from IDO and PD-L1 designed to elicit Th1/CD8+ T-cell responses against IDO- and PD-L1–expressing cells, reducing immunosuppressive cells and reprogramming the tumor microenvironment. Targets/pathways: PD-1/PD-L1 axis, IDO1 tryptophan-catabolism pathway, effector T cells, tumor cells, regulatory T cells, myeloid-derived suppressor cells, and tumor-associated macrophages.