drugset / Trial / NCT01409187

IPI-Biotherapy for Patients Previously Treated With Cytotoxic Drugs With Metastatic Melanoma

NCT01409187

Phase 1/2 Withdrawn M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Intron-A (interferon alfa-2b) and Proleukin (aldesleukin, IL-2) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.

Timeline

Start
2011-10
Primary completion
2016-10
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 2 mg/kg Intravenous
Subject aldesleukin Protein / enzyme biologic 9 unknown Intravenous
Subject interferon alfa-2b Protein / enzyme biologic 5 unknown Subcutaneous

Indications