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[DKFZ-2026-01009]
Journal Article
Hassel, J. ; Arance, A. ; Carlino, M. S. ; et al
IO102-IO103 immune-modulatory cancer vaccine and pembrolizumab in melanoma.
IO102-IO103, an investigational, immune-modulatory cancer vaccine, targets both tumor cells and immune-suppressive cells within the tumor microenvironment through activation and expansion of T cells against indoleamine 2,3-dioxygenase 1(IDO1)-positive and/or programmed death ligand 1 (PD-L1)-positive cells.This open-label, Phase 3 trial randomized 407 patients with untreated advanced melanoma in a 1:1 ratio to receive subcutaneous IO102-IO103 (85 μg each) plus pembrolizumab 200 mg intravenously every 3 weeks or pembrolizumab alone for up to 2 years. The primary endpoint was progression-free survival (PFS) by blinded independent central review per RECIST v1.1.The median PFS was 19.4 months (95% confidence interval [CI], 9.7 to not reached) for IO102-IO103 plus pembrolizumab versus 11.0 months (95% CI, 6.0 to 14.8) for pembrolizumab (hazard ratio [HR] [95% CI], 0.77 [0.58 to 1.00]; P = 0.0558); the statistical significance threshold (P ≤ 0.045) was missed. [...]
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