Study design and participants
Melanoma, allergic, toxicity, autoimmune diseases, extracranial lesion, HCV infection, primary mucosal melanoma
CONGENITAL IMMUNODEFICIENCY DISEASE, DISEASE PROGRESSION, MELANOMA, DISEASE, AUTOIMMUNE DISEASES, HUMAN IMMUNODEFICIENCY VIRUS INFECTION, ONCOLOGY, METASTATIC MELANOMA
This clinical trial is a multi-center, open-label, single-arm phase II study. Eligible patients were aged 18 to 75 with a histologic diagnosis of unresectable locally advanced or metastatic melanoma and must have failed at least 1 prior routine regimen for the advanced disease. The number of patients with primary mucosal melanoma should be less than 22%. The Eastern Cooperative Oncology Group (ECOG) performance status of the patients must be scored 0 or 1, and with a life expectancy ≥ 3 months. There must be at least 1 measurable extracranial lesion based on RECIST v1.1 [The major exclusion criteria included: Melanoma of ocular origin; Prior treatments contained anti-PD-1/PD-L1/CTLA-4 antibody; Patients with active or history of autoimmune diseases that may recur, or with high risk; Expecting to receive major surgery during the study period; Needing to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study period; history of human immunodeficiency virus infection, acquired or congenital immunodeficiency disease, organ transplantation or stem cell transplantation; having active chronic HBV or HCV infection, except those with HBV DNA viral load ≤ 500 IU/mL or < 10^3 copies/mL, or HCV RNA negative after adequate treatment; Known to be allergic to macromolecular protein agents or monoclonal antibody; Have participated in other clinical trial within 4 weeks prior to the first dose of the study drug.Eligible patients received Pucotenlimab 3 mg/kg by intravenous infusion over 60 min on day 1, every 3 weeks until disease progression, intolerable toxicity, or treatment discontinuation for any other reasons.