Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Prior treatment

• Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
• Taken an investigational drug within 28 days prior to enrolment

Other illness

• History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.

Other

• Patient will be excluded from this study if he/she meets any of the following criteria:
• Known ocular melanoma
• Patient is not able to comply with the planned study procedures

• Patient(s) must meet all of the following criteria to be eligible for inclusion:
• ≥18 years old of age at the time of informed consent and of Chinese descent
• Signed written informed consent
• Going to receive commercial dabrafenib and trametinib according to approved label
• Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:
  • for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma
  • for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck
  • for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition
• Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
• Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1