A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

Inclusion Criteria:

- Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable)
or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using
the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011).
The assay will be conducted by a central reference laboratory. Subjects with ocular
or mucosal melanoma are not eligible.

- The subject must have a radiologically measurable tumor

- The subject is able to carry out daily life activities without significant difficulty
(ECOG performance status score of 0 or 1).

- Able to swallow and retain oral medication

- Sexually active subjects must use acceptable methods of contraception during the
course of the study

- Adequate organ system function and blood counts

Exclusion Criteria:

- Prior treatment with a BRAF or a MEK inhibitor

- Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV
(metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed.
(Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)

- The subject has received major surgery or certain tyes of cancer therapy with 21 days
of starting treatment

- Current use of prohibited medication listed in the protocol

- Left ventricular ejection fraction less than the lower limit of normal

- Uncontrolled blood pressurl

- History or current evidence of retinal vein occlusion or central serous retinopathy

- Brain metastases unless previously treated with surgery or stereotactic radiosurgery
and the disease has been stable for at least 12 weeks

- The subject is pregnant or nursing