eligibility_summary
Include: HLA‑A02:01+ Stage IV or unresectable Stage III melanoma, adequate tumor tissue, measurable disease, BRAF V600 status, ECOG 0–1, use effective contraception to 5 months post‑dose. Exclude: other cancers, active/untreated CNS mets/meningitis, hypersensitivity to IMC‑F106C, nivolumab or relatlimab, pulmonary/cardiac disease, autoimmune needing immunosuppression, poorly controlled illness, prior systemic therapy for advanced melanoma, prior life‑threatening AE to PD‑(L)1 or LAG‑3.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 PRISM-MEL-301 tests brenetafusp (IMC-F106C) + nivolumab vs standard nivolumab regimens (nivolumab ± relatlimab) in untreated, HLA‑A02:01–positive advanced melanoma. Brenetafusp is an ImmTAC (bispecific, soluble, affinity‑enhanced PRAME‑specific TCR fused to anti‑CD3 scFv) that binds PRAME peptide presented by HLA‑A02:01 on tumor cells and recruits/activates polyclonal T cells via CD3 to kill PRAME+ cells. Nivolumab is an anti‑PD‑1 monoclonal antibody checkpoint inhibitor that restores T‑cell activity by blocking the PD‑1/PD‑L1 pathway. Relatlimab is an anti‑LAG‑3 monoclonal antibody checkpoint inhibitor (used with nivolumab as Opdualag) that relieves LAG‑3–mediated T‑cell inhibition. Targets/cells/pathways: PRAME/HLA‑A02:01 on melanoma cells, CD3 on T cells, PD‑1 and LAG‑3 inhibitory pathways on exhausted T cells.