drugset / Trial / NCT01603212

Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

NCT01603212

Phase 1 Completed 6 enrolled 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 vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied. The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.

Timeline

Start
2013-07-18
Primary completion
2017-07-05
Completion
2017-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Vemurafenib Small molecule 480 mg Oral
Subject Vemurafenib Small molecule 720 mg Oral
Subject Vemurafenib Small molecule 960 mg Oral
Subject aldesleukin Protein / enzyme biologic 5 unknown Intravenous
Subject aldesleukin Protein / enzyme biologic 7 unknown Intravenous
Subject aldesleukin Protein / enzyme biologic 9 unknown Intravenous
Background interferon alfa-2b Protein / enzyme biologic 5 unknown Subcutaneous

Indications