drugset / Trial / NCT01608594

Neoadjuvant Combination Therapy With Ipilimumab and HighDose IFN-α2b for Melanoma

NCT01608594

Phase 1 Completed 30 enrolled Diwakar Davar
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and potential effectiveness of a new treatment for advanced and recurrent melanoma involving the combination of Ipilimumab and IFN-α2b before surgery and to test for biomarker studies in blood and/or tumor to better understand this disease, how best to treat it and what patients should be treated with this combination.

Timeline

Start
2013-05-21
Primary completion
2017-02-14
Completion
2017-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous
Background interferon alfa-2b Protein / enzyme biologic 10 unknown Intravenous

Indications