Unresectable, or metastatic (advanced) melanoma (IO Biotech).

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

Open-label, randomized, clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma.

Phase 3, international, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

Patients will be stratified on the basis of the following factors: Disease stage: Unresectable stage IIID or stage IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type.

Inclusions/Exclusions: Stage III or IV melanoma. Treatment naïve in unresectable setting. ECOG 0-1. Measurable disease by RECIST. No uveal or ocular melanoma allowed. Stable brain metastasis allowed. No HIV.

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