Study with dabrafenibe, a BRAF inhibitor, in combination with trametinibe, a MEK inhibitor, compared to two placebos (inactive medicaments) in the treatment of positive melanoma V600E/K BRAF mutation after surgery
- Conditions
- Malignant melanoma of skinC43.9
- Registration Number
- RBR-9xrw6x
- Lead Sponsor
- GlaxoSmithKline Brasil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint of this study is relapse free survival (RFS) which is defined as the time from randomization to disease recurrence or death from any cause.<br>Recurrence of or death from the same cancer and all deaths from other causes are events. Treatment emergent malignancies (excluding second melanomas) will not be considered as events, and loss to follow-up is censored.<br>
- Secondary Outcome Measures
Name Time Method