NCT01253096

Intratumoral Application of L19IL2 in Patients With Malignant Melanoma

A Phase II Study of Intratumoral Application of L19IL2 in Patients With Stage III/IV Melanoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, non-randomized, multicenter, prospective study designed to test the efficacy and safety of intratumorally administered L19IL2 in patients suffering from metastatic melanoma.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Intratumoral injections of L19IL2	Patients will be treated with intratumoral injections of L19IL2 1-3 x weekly. The maximum cumulative dose per week is 20 MioIU. Treatment duration is up to 20 weeks.

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-12-03
• Last updated: 2014-11-20

Locations

3 sites across 2 countries: Austria, Germany