drugset / Trial / NCT02076646

A Phase I/II Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma

NCT02076646

Phase 1/2 Unknown 96 enrolled Philogen S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, open-label, multi-center, Phase I/II study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma.

Timeline

Start
2013-07-31
Primary completion
2016-05-17
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dacarbazine Small molecule 1000 mg/m2 Intravenous
Subject Darleukin Protein / enzyme biologic 480000 iu/kg
Subject Darleukin Protein / enzyme biologic 640000 iu/kg
Subject Darleukin Protein / enzyme biologic 800000 iu/kg

Indications