eligibility_summary
Eligible: adults ≥18 with unresectable stage III/IV melanoma progressed after ≥1 systemic therapy, MC1R+ uptake on [68Ga]VMT02 or [203Pb]VMT01 imaging, measurable disease, ECOG 0–1, adequate organ function, life ≥3 mo, washout 21d (IV) or 7d (oral), contraception. Exclude: active 2nd cancer, prior systemic radionuclides, pregnancy, recent infection/fever, recent INDs, substance abuse, noncompliance. With nivolumab: exclude untreated CNS mets, autoimmune disease/immunosuppression, HBV/HCV/HIV/AIDS, complementary meds, live vaccine, abnormal labs, unresolved immune toxicities, or nivolumab allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05655312 tests MC1R-targeted radiotheranostics with/without immunotherapy in advanced melanoma. Interventions: (1) [212Pb]VMT01: a peptide radiopharmaceutical (targeted alpha-particle therapy). It binds melanocortin-1 receptor (MC1R) on melanoma cells and delivers alpha radiation (via 212Pb→212Bi/212Po), producing high-LET, short-range DNA double‑strand breaks and tumor cell kill. Given IV every ~8 weeks as mono- or combo-therapy. (2) [203Pb]VMT01 and [68Ga]VMT02: MC1R-targeted imaging agents (SPECT/CT and PET) used for patient selection and dosimetry. (3) Nivolumab: an anti–PD-1 IgG4 monoclonal antibody checkpoint inhibitor, IV q4w, to restore T-cell antitumor activity. Targets/pathways: MC1R on melanoma cells, DNA damage response from alpha radiation, PD‑1/PD‑L1 immune checkpoint on T cells to enhance antitumor immunity.