Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Inclusion Criteria:

- ECOG Performance Status range of 0-2

- Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.

- May be systemic naïve or received up to two previous systemic treatment regimens for
metastatic melanoma.

- Must be able to undergo MRI and have at least one measurable intracranial lesion for
which specific criteria have to be met.

Exclusion Criteria:

- Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular
signal-regulated kinase inhibitor.

- Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without
delayed toxicity within treatment specific timeframe.

- Treatment with stereotactic radiosurgery or treatment with whole-brain radiation
within treatment specific timeframe.

- Any presence of leptomeningeal disease or any parenchymal brain metastasis

- History of another malignancy, some exceptions may apply.

- A history or evidence of cardiovascular risk- specific criteria have to be met

- A history or current evidence/risk of retinal vein occlusion or retinal pigment
epithelial detachment - specific criteria have to be met.