Autologous monocyte-derived DC vaccination combined with cisplatin in stage III and IV melanoma patients: a prospective, randomized phase 2 trial

摘要: Autologous dendritic cell (DC) vaccines can induce tumor-specific T cells, but their effect be counteracted by immunosuppressive mechanisms. Cisplatin has shown immunomodulatory effects in vivo which may enhance efficacy of DC vaccination. This is a prospective, randomized, open-label phase 2 study (NCT02285413) including stage III and IV melanoma patients receiving 3 biweekly vaccinations gp100 tyrosinase mRNA-loaded monocyte-derived DCs with or without cisplatin. Primary objectives were to immunogenicity feasibility, secondary assess toxicity survival. Twenty-two 32 analyzed. Antigen-specific CD8+ cells found 44% versus 67% functional responses 28% 19% skin-test infiltrating lymphocytes vaccination cisplatin, respectively. Four stopped cisplatin because continued monotherapy. No therapy-related grade 4 adverse events occurred due During combination therapy, one event, decompensated heart failure fluid overload, occurred. The clinical outcome parameters did not clearly suggest significant differences. Combination feasible safe, does seem result more improved outcome, when compared