A Phase II Study of Intratumoral Application of L19IL2 in Patients With Stage III/IV Melanoma.
Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and
safety of intratumorally administered L19IL2. L19IL2 binds with high affinity to the EDB
domain of Fibronectin, a marker of angiogenesis which is strongly upregulated in malignant
melanoma lesions. This binding leads to an increased residence time of the protein at the
site of disease. The biologic effect of the IL2 moiety is identical to the one of free IL-2.
The study treatment is up to 20 MioIU L19IL2 per week in patients suffering from
histopathologically-proven malignant melanoma with presence of injectable soft-tissue
metastases either in clinical stage III or stage IV M1a without visceral metastases. The
duration of treatment could be up to 20 weeks. After the end of study visit follow-up is
performed every 6 weeks until 12 months from enrollment of each patient.
Tumor assessment will be performed within 2 weeks before start of treatment and at week 12
using immune-related response criteria and RECIST 1.1. To assure that patients do not
develop visceral metastases under treatment, an additional tumor assessment will be
performed already at week 6 after start of therapy. Assessments at week 24 and 36 will be
performed according to RECIST vs. 1.1 criteria only.
Treatment emergent adverse events will be summarized by Common Toxicity Criteria (version
4.02, CTCAE) and worst grade for all treated patients. Laboratory values and change in vital
signs will be summarized.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of patients with complete response (CR) of L19IL2 treated Index/Non-Index lesions at week 12 .
Claus Garbe, Prof. M.D.
University Hospital Tuebingen (Germany)
Italy: Ethics Committee