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 (LN metastasis \>1 mm), IIIB, IIIC, IIID \[AJCC (ed 8)\] no more than 12 weeks, from last surgery, before Day 1

  1. Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible.
  2. Subjects who had previously had Stage III melanoma at any time were not eligible.
  3. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling 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 to chemotherapy, checkpoint inhibitors, targeted therapy \[e.g., BRAF and/or MEK inhibitors\], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and had not recurred within 2 years prior to study treatment; completely resected basal cell and 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 serous retinopathy