BRF115532 - A study Phase III, randomized, double-blind, dabrafenibe (GSK2118436) in combination with trametinibe (GSK1120212) versus two placebo in the adjuvant treatment of high-risk melanoma with BRAF mutation positive V600, after surgical resection

GlaxoSmithKline Brasil0 个研究点开始时间: 2016年9月22日最近更新: 2023年5月29日

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•Completely resected histologically confirmed high-risk, stage IIIa, LN metastasis more than 1 mm, IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible;
•Surgically rendered free of disease no more than 12 weeks before randomization;
•Recovered from definitive surgery, e.g. no uncontrolled wound infections or indwelling drains;
•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 metastases;
•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 more than 5 years;
•History or current evidence of cardiovascular risk;
•History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

发起方

GlaxoSmithKline Brasil