UI Hospitals and Clinics

Clinical Trial Details

Short Title
Official Title
A phase III, randomized, open-label study comparing the combination of the BRAF inhibitor, GSK2118436 and the MEK inhibitor, GSK1120212 to the BRAF inhibitor vemurafenib in subjects with advanced (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive melanoma
Description

The purpose of this study is to test the safety of dabrafenib, which targets the BRAF gene and trametinib, which aims at a different cell signalling gene called MEK. Investigators also would like to see how well they work together compared to another drug vemurafenib, also known as Zelboraf®, which also targets the BRAF gene. Participants in this study will receive both dabrafenib and trametinib in combination together or receive vemurafenib alone.

Dabrafenib and trametinib are not approved for doctors to prescribe to patients. Vemurafenib (Zelboraf®) is approved for certain types of advanced melanoma and is available in some countries but not everywhere.

About 1000 patients have received dabrafenib, about 1220 have received trametinib and about 360 have received the combination of dabrafenib and trametinib in other studies, so far.

About 700 people in 30 countries will take part in this study. The type of melanoma a participant must have in order to take part in this study occurs in about half of the people that have melanoma.

Start Date
January 7, 2013
End Date
May 3, 2013
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Mohammed Milhem, MD
Contact Info

Melanie Frees, 319-356-1228

Department
Keywords
advanced melanoma ; BRAF gene ; cancer ; dabrafenib ; IRB#201210501 ; MEK ; melanoma ; milhem ; phase 3 ; phase III ; trametinib ; vemurafenib (Zelboraf®) ;

We welcome your feedback! Please help us improve your experience on our website by completing a brief survey.