IRB #

IRB00008657

Title

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

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of this study is to find out the effects (good and/or bad) of dabrafenib and trametinib compared to another drug (vemurafenib) has on subjects with unresectable (stage IIIc) or metastatic (stage IV) cutaneous melanoma with BRAF V600E/K mutation

Medical Condition(s)

Melanoma, skin

Eligibility Criteria

Subjects must be 18 years or older
Subjects must have cutaneous melanoma, not curable with surgery, and measurable with a CT scan
Subjects cannot participate if they have had prior treatment with a BRAF inhibitor or MEK inhibitor

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

GlaxoSmithKline

Recruitment End

Compensation Provided

No