This Phase II clinical study is an open-label, multicenter study of L19IL2 in combination
with Dacarbazine in patients with metastatic melanoma.
The study is divided in two parts: a phase IIa part, designed to establish the recommended
dose (RD) of L19IL2 when administered in combination with a fixed dose of Dacarbazine, as
well as to determine the preliminary tolerability profile; the second phase IIb part
evaluates the objective response rate (ORR) including a randomized study with a fixed dose of
Dacarbazine with or without L19IL2, dosed at the RD determined in phase IIa.