Phase II Study Comparing Sintilimab Plus Chemotherapy to Chemotherapy Alone as Additional Treatment for PD-L1-Positive Mucosal Melanoma After Complete Surgery

What this Trial Is About

Melanoma, particularly mucosal melanoma, is a rapidly increasing cancer in East Asia with significant incidence and mortality rates. This trial evaluates the combination of sintilimab and chemotherapy compared to chemotherapy alone for patients with PD-L1-positive mucosal melanoma that has been completely removed by surgery. The purpose is to gather more clinical evidence on the best adjuvant treatment options for this condition. Participants in this phase II study receive either sintilimab combined with chemotherapy or chemotherapy alone. Sintilimab is given intravenously every three weeks for six cycles followed by maintenance therapy for one year. Chemotherapy includes dacarbazine or temozolomide daily for five days plus cisplatin intravenously for three days every three weeks, administered over six cycles. This study is randomized with single masking and involves multiple centers. During the trial, participants undergo careful monitoring including imaging and physical exams to confirm no recurrence before treatment. Researchers assess recurrence-free survival over two years and overall survival over three years, along with treatment side effects. Safety is monitored up to 30 days after treatment ends. Participants are expected to comply with all visits and procedures throughout the study period, which extends up to several years for follow-up.

Sintilimab Combined With Chemotherapy for Adjuvant Treatment of Mucosal Melanoma After Surgery