DARLEUKIN (L19-IL2)

PH-L19-IL2-03/09

Study protocol title: A Phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma.

Study purpose: Rate of patients with complete response (CR) of L19IL2 treated metastases at week 12.Safety of intratumoral administration of L19IL2.Rate of patients with CR, partial response (PR) and stable disease (SD) of L19IL2 treated. metastases at week 12 (objective response rate and disease control rate of L19IL2 treated metastases).Duration of objective response and disease control of L19IL2 treated metastases.Rate of patients with CR, PR and SD of all metastases at week 12 (objective response rate and disease control rate of all metastases).Duration of objective response and disease control of all metastases.Overall survival (OS). Quality of life.

Number of patients: 30 patients will be enrolled.

Current status: Open

Study centers:

• Universitäts-Hautklinik Sektion Dermatologische Onkologie Liebermeisterstr 25 – 72076 Tübingen, Germany

• Istituto Europeo di Oncologia, Divisione di Medicina Nucleare, Via Ripamonti 435 –20141 Milano, Italy.

• Medizinischen Universität Graz, LKH-Universitätsklinikum – Eingangsgebäude, Auenbruggerplatz 8, A-8036 Graz, Austria.

• Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1 - 30625 Hannover, Germany.