FIBROMUN (L19-TNF)

PH-L19-TNFαILP-01/08

Study protocol title: Phase I dose-finding study of tumor-targeting human monoclonal antibody-cytokine fusion protein L19TNFα plus melphalan using isolated inferior limb perfusion (ILP) in patients with in-transit stage III/IV melanoma.

Study purpose: For Phase I, the primary objective is based on safety data only. However, efficacy variables such as tumor response will also be evaluated.

Number of patients: 17 subjects.

Current status: 

• Phase I: completed.

Study centers:

• Dipartimento di Discipline Chirurgiche, Morfologiche e Metodologie Integrate (D.I.C.M.I.) – Università di Genova, Azienda Ospedaliera S. Martino, Largo Rosanna Benzi 10 – 16132 Genova, Italy.

• Struttura Complessa Chirurgia Generale 5 (Melanoma e Sarcoma), Istituto Nazionale Tumori, Via Venezian 1 – 20133 Milano, Italy.