Real-world study of SHR-1210 plus apatinib in the treatment of BRAF-negative mucosal melanoma: efficacy, safety and implications of precision medicine

Background: Mucosal melanomas arise from melanocytes in mucosal tissues, and it's usually detected at a late stage owing to its anatomic location. Advances in immunotherapies have proved to be promising therapeutic approaches for advanced mucosal melanoma patients, however, clinical studies have shown mucosal melanoma patients are less responsive to ICIs than cutaneous melanoma. Effective therapy is still lacking. Objective: To investigate the efficacy and safety of SHR-1210 (an anti-programmed cell death-1 antibody) in combination with Apatinib (a vascular endothelial growth factor receptor 2 inhibitor) as late-line treatment in patients with advanced mucosal melanoma (Ethics approval number 2019184;ClinicalTrials.gov ID: NCT03986515). Patients and methods: Patients with confirmed metastatic mucosal melanoma according to AJCC 8.0. In this single-arm, single-center, phase II nonrandomized clinical trial, patients with advanced mucosal melanoma who have received several line treatments were enrolled between 2019.06 and 2022.12. The data cutoff date was June 11th, 2025. Patients received 200mg SHR-1210 intravenously every 3 weeks, and oral Apatinib 250 mg daily until unacceptable toxic effects or disease progression. Results: A total of 13 patients were enrolled and received treatment. The disease control rate (DCR) reached 100% (SD = 13). The objective response rate (ORR) was 0%. The estimated median overall survival (OS) was 29.9 months (95% CI 15.26-44.54),. The estimated median progression-free survival (PFS) was 5.17 months (95% CI 3.27-10.27),. The most common grade 1-2 was hand and foot induration with desquamation and pain, and one case of grade 4 abnormal liver function and grade 3 hypertension. No treatment-related deaths occurred. Conclusions: This suggests that this combination therapy model may be a promising disease control for mucosal melanomas. However, the sample size is relatively small and needs to be increased for further research. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT03986515, identifier NCT03986515.