IIIB/C 期黑色素瘤的辅助树突状细胞治疗：MIND-DC 随机 III 期试验

Autologous natural dendritic cells (nDCs) treatment can induce tumor-specific immune responses and clinical responses in cancer patients. In this phase III clinical trial (NCT02993315), 148 patients with resected stage IIIB/C melanoma were randomized to adjuvant treatment with nDCs (n = 99) or placebo (n = 49). Active treatment consisted of intranodally injected autologous CD1c+ conventional and plasmacytoid DCs loaded with tumor antigens. The primary endpoint was the 2-year recurrence-free survival (RFS) rate, whereas the secondary endpoints included median RFS, 2-year and median overall survival, adverse event profile, and immunological response The 2-year RFS rate was 36.

8% in the nDC treatment group and 46. 9% in the control group (p = 0. 31). Median RFS was 12. 7 months vs 19. 9 months, respectively (hazard ratio 1. 25; 90% CI: 0. 88-1. 79; p = 0. 29). Median overall survival was not reached in both treatment groups (hazard ratio 1. 32; 90% CI: 0.

73-2. 38; p = 0. 44). Grade 3-4 study-related adverse events occurred in 5% and 6% of patients. Functional antigen-specific T cell responses could be detected in 67. 1% of patients tested in the nDC treatment group vs 3. 8% of patients tested in the control group (p < 0. 001).

In conclusion, while adjuvant nDC treatment in stage IIIB/C melanoma patients generated specific immune responses and was well tolerated, no benefit in RFS was observed.