Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Inclusion Criteria:

- >= 18 years of age

- Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

- Measurable disease according to RECIST 1.1

- Women of childbearing potential with negative serum pregnancy test prior to
randomisation

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate baseline organ function

Exclusion Criteria:

- Any prior use of a BRAF or MEK inhibitor

- Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior
systemic treatment in the adjuvant setting is allowed

- History of another malignancy (except subjects who have been disease free for 3 years
or with a history of completely resected non-melanoma skin cancer)

- Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which
will be allowed)

- Brain metastases (except if all known lesions were previously treated with surgery or
stereotactic radiosurgery and lesions, if still present, are confirmed stable for >=
12 weeks prior to randomisation or if no longer present are confirmed no evidence of
disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for
>= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4
weeks prior to randomisation

- History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood
pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by
anti-hypertensive therapy)

- History or current evidence/risk of retinal vein occlusion (RVO) or central serous
retinopathy (CSR)