drugset / Trial / NCT02076633

Intratumoral Administration of L19IL2/L19TNF

NCT02076633

Phase 2 Completed 21 enrolled Philogen S.p.A.
NaSingle-groupOpen-labelTreatment

Summary

This Phase II study is an uncontrolled, multicenter, prospective study for patients with malignant melanoma of the skin in clinical stage III or stage IV M1a. Twenty Patients will be treated with a mixture of L19IL2 and L19TNF once weekly for up to 4 weeks. The dose will be distributed among the lesions via multiple intralesional injections. The proportion of patients with complete response at week 12 will be calculated.

Timeline

Start
2012-12
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Darleukin Protein / enzyme biologic 1e+07 iu Other
Subject Onfekafusp alfa Protein / enzyme biologic 312 ug Other

Indications