This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.
Study Type
EXPANDED_ACCESS
Trametinib will be provided as tablets containing 0.5 milligram (mg) or 2.0 mg of trametinib parent (present as the DMSO solvate). The starting dose of trametinib will be administered orally 2.0 mg, once daily (QD)
Dabrafenib is commercially available as capsules containing 50 mg or 75 mg as free base (present as the mesylate salt). Dabrafenib will be administered orally 150 mg, twice daily (BID).
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GSK Investigational Site
Amiens, France
GSK Investigational Site
Angers, France
GSK Investigational Site
Bayonne, France
GSK Investigational Site
Besançon, France
GSK Investigational Site
Bobigny, France
GSK Investigational Site
Bordeaux, France
GSK Investigational Site
Boulogne-Billancourt, France
GSK Investigational Site
Brest, France
GSK Investigational Site
Caen, France
GSK Investigational Site
Chambray-lès-Tours, France
...and 36 more locations