eligibility_summary
Adults ≥18 with resectable, measurable cutaneous stage III melanoma with nodal disease or resectable stage III/IVA SCCHN (oral cavity, HPV−/p16− oropharynx, hypopharynx, larynx). ECOG 0–1, controlled HIV and treated HBV/HCV allowed. Exclusions: non‑cutaneous/oligometastatic or in‑transit melanoma, nasopharyngeal SCCHN, prior index tumor therapy, recent investigational/chemo/RT or live vax, immunosuppression/autoimmune, other active cancer/transplant, infection/hepatitis, severe pembro allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05280314 tests IO102-IO103 plus pembrolizumab as neoadjuvant and adjuvant therapy in resectable stage III melanoma and resectable stage III–IVA (HPV‑negative) SCCHN, one melanoma cohort randomizes vs pembrolizumab alone. IO102-IO103: a subcutaneous therapeutic peptide vaccine (IO102: IDO1 peptide, IO103: PD‑L1 peptide) formulated with Montanide ISA 51 VG. Mechanism: induces antigen‑specific cytotoxic and helper T‑cell responses against IDO1‑ and PD‑L1‑expressing cells, reducing immunosuppressive cell populations and enhancing antitumor immunity. Pembrolizumab: an anti‑PD‑1 monoclonal antibody checkpoint inhibitor that blocks PD‑1 on T cells to restore effector function. Targets/pathways: IDO1 (tryptophan‑kynurenine immunosuppressive pathway), PD‑L1 on tumor/myeloid cells, PD‑1 on T cells—aiming to increase activated tumor‑infiltrating T cells and tumor cell killing.