A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma
ID Number 12-1814Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to test two experimental drugs in combination, dabrafenib which
targets the BRAF gene and trametinib which aims at a different cell signaling gene called MEK
and see how well they work together compared to another drug vemurafenib (also known as
Zelboraf®) which also targets the BRAF gene, for treating metastatic melanoma.
An experimental drug is not approved by the United States Food and Drug Administration (FDA)
for use except in research studies. 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. Vemurafenib is FDA approved in the United States.
If you participate in this study you will receive both dabrafenib and trametinib in combination
together or you will receive vemurafenib alone.
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.
Recruiting Patients: Yes