eligibility_summary
Adults (≥18) with primary non‑metastatic uveal melanoma (not iris) after definitive surgery/radiation, randomization ≤12 wks post‑treatment. High‑risk: AJCC8 stage III or genetic (monosomy 3 or GEP class 2, stage I/II only if genetic). ECOG 0–1, HLA‑A02:01+, no recurrence on recent imaging, adequate organs, contraception/non‑pregnant, consent. Exclude significant cardiac disease/QTcF>470/recent MI, active infections (HBV/HCV/HIV) unless controlled, other cancers, autoimmune on immunosuppression, noncompliance, tracer/contrast/MRI/CT contraindications.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Randomized Phase III adjuvant study in high‑risk, HLA‑A02:01–positive uveal melanoma after definitive local therapy. Interventions: Tebentafusp (IMCgp100) vs observation. Drug type/mechanism: Tebentafusp is a bispecific TCR–anti‑CD3 ImmTAC biologic (T‑cell engager). Its affinity‑enhanced TCR binds the gp100 (PMEL) peptide presented by HLA‑A02:01 on melanoma cells, while its anti‑CD3 domain recruits and activates polyclonal T cells, triggering TCR/CD3 signaling, immune synapse formation, cytokine release, and tumor cell lysis. Dosing: IV weekly with step‑up (20→30→68 mcg) then 68 mcg weekly for 6 months. Targets (cells/pathways): Tumor cells expressing gp100 in the context of HLA‑A02:01, CD3 on T cells, pathways include T‑cell activation and cytotoxic effector functions. Comparator: observation (no drug). Objective: reduce recurrence risk.