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-μm-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.