drugset
drugset / Trial / NCT01672450

A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma

NCT01672450 ↗

Phase 1 Completed 12 enrolled University of Utah
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.

Timeline

Start
2012-09
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 0.1 mg Other
Subject Ipilimumab Monoclonal antibody 0.25 mg Other
Subject Ipilimumab Monoclonal antibody 0.5 mg Other
Subject Ipilimumab Monoclonal antibody 1 mg Other
Subject Ipilimumab Monoclonal antibody 2 mg Other
Background aldesleukin Protein / enzyme biologic 0.003 iu Other

Indications

melanoma