COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
- Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis
>1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation
positive by a central laboratory.
- Surgically rendered free of disease no more than 12 weeks before randomization.
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate hematologic, hepatic, renal and cardiac function.
- Known mucosal or ocular melanoma or the presence of unresectable in-transit
- Evidence of distant metastatic disease.
- Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for
melanoma is allowed.
- History of another malignancy or concurrent malignancy including prior malignant
melanoma. Exceptions to this include: Patients who have been disease-free for 5 years
or patients with a history completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible, for example cervical cancer in
situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary
melanomas, or other malignancies for which the patient has been disease free for > 5
- History or current evidence of cardiovascular risk.
- History or current evidence of retinal vein occlusion (RVO) or central serous