Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen Vaccine for the Treatment of Stage IV Melanoma

Objective: To evaluate the activity of interleukin-2 (IL-2) in combination with allogeneic large multivalent immunogen (LMI) vaccine, prepared by immobilizing SK23-CD80(+) melanoma cell line plasma membrane on 5-mm-diameter silica beads, in patients with melanoma. Methods: Twenty-one patients with metastatic melanoma were randomly assigned to an IL-2 alone control group or an IL-2 plus LMI vaccine treatment group. The primary objective was to evaluate the progression-free survival (PFS) of each group. Secondary clinical objectives included median overall survival (OS) and 1- and 2-year rates of OS. Results: Treatment was very well tolerated. Median PFS was no different between the treatment arm (2.20 mo) and control arm (1.95 mo). Median OS was also similar for the treatment arm (11.89 mo) and control arm (9.97 mo). Conclusions: This study failed to demonstrate that allogeneic LMI vaccine and low-dose IL-2 improved survival in patients with melanoma as compared with low-dose IL-2 alone.