Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis

Pts receiving TLPO and TLPLDC (without G-CSF) vaccines had significantly improved DFS and OS compared to placebo, while outcomes in the TLPLDC+G arm remained similar to placebo. DFS was 60.9% (TLPO), 55.4% (TLPLDC), 22.9% (TLPLDC+G), and 27.2% (placebo); OS followed the same pattern. Only two pts across all arms experienced a related adverse event ≥grade 3. Given manufacturing advantages, a phase 3 trial to confirm the efficacy of the TLPO vaccine is planned.