eligibility_summary
Adults ≥18 with consent, histologically confirmed unresectable stage III/IV melanoma (non-uveal), no prior systemic therapy for unresectable disease (neoadjuvant/adjuvant ICI or BRAF/MEK allowed if >6 mo), ≥1 measurable extracranial/extraskeletal lesion, ECOG ≤1, adequate labs (Hgb≥9, WBC≥2000, Plt≥100k, bili≤1.5×ULN or Gilbert’s<3 mg/dL, AST/ALT≤2.5×ULN, CrCl≥15), contraception required. Exclude untreated/leptomeningeal CNS mets (treated asymptomatic allowed), recent immunosuppression or live vaccine, autoimmune motor neuropathy, other active malignancy, severe allergy, uncontrolled illness, active HBV/HCV, pregnancy/breastfeeding, prisoners/compulsorily detained.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in untreated, unresectable stage III/IV melanoma testing: 1) IO102/IO103 – subcutaneous long‑peptide vaccines targeting IDO (IO102) and PD‑L1 (IO103). Type: therapeutic cancer vaccines that elicit IDO/PD‑L1–specific CD4/CD8 T cells to eliminate IDO/PD‑L1–expressing tumor and immunosuppressive cells, reshaping the tumor microenvironment. 2) Nivolumab – anti‑PD‑1 IgG4 monoclonal antibody (checkpoint inhibitor) restoring T‑cell activity. 3) Relatlimab – anti‑LAG‑3 IgG4 monoclonal antibody (checkpoint inhibitor) relieving T‑cell exhaustion. Targets/pathways: PD‑1/PD‑L1 axis, LAG‑3 checkpoint on exhausted T cells, and IDO/kynurenine immunosuppressive metabolic pathway on tumor cells and suppressive APCs/MDSCs/macrophages.