Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Key Inclusion Criteria:

• Completely resected histologically confirmed cutaneous melanoma stage IIIA (LNmetastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)] no more than 12 weeks, from lastsurgery, before Day 1

1. Subjects presenting with initial resectable lymph node recurrence after adiagnosis of Stage I or II melanoma were eligible.

2. Subjects who had previously had Stage III melanoma at any time were noteligible.

3. Recovered from definitive surgery (e.g. no uncontrolled wound infections orindwelling drains).

• V600E/K mutation positive using a validated local test

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

Key Exclusion Criteria:

• Uveal or mucosal melanoma

• Evidence of metastatic disease including unresectable in-transit metastasis

• Received any prior adjuvant or neoadjuvant treatment, including but not limited tochemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEKinhibitors], biologic therapy, vaccine therapy, investigational treatment, orradiotherapy for melanoma

• Malignant disease, other than that being treated in this study. Exceptions to thisexclusion include the following: malignancies that were treated curatively and hadnot recurred within 2 years prior to study treatment; completely resected basal celland squamous cell skin cancers and any completely resected carcinoma in situ

• History or current evidence of cardiovascular risk

• A history or current evidence/risk of retinal vein occlusion (RVO) or central serousretinopathy