LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

April 4, 2013

Primary Completion Date

November 3, 2017

Study Completion Date

September 17, 2020

Conditions
Stage III MelanomaStage IV MelanomaUnresectable MelanomaBRAF Mutant Melanoma
Interventions
DRUG

BRAF inhibitor dabrafenib and MEK inhibitor trametinib

Patients will receive the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle will be defined as 3 weeks in duration. Cycles will be repeated until disease progression (clinical or radiological). Patients may remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.

Trial Locations (1)

27599

Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT01726738 - LCCC 1128: Open Label Phase II Trial of the BRAF Inhibitor (Dabrafenib) and the MEK Inhibitor (Trametinib) in Unresectable Stage III and Stage IV BRAF Mutant Melanoma; Correlation of Resistance With the Kinome and Functional Mutations | Biotech Hunter | Biotech Hunter