drugset / Trial / NCT01856023

HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

NCT01856023

RandomizedSequentialOpen-labelTreatment

Summary

Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of ipilimumab. Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of HD IL-2.

Timeline

Start
2013-05
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Comparator aldesleukin Protein / enzyme biologic 600000 iu/kg Intravenous

Indications