A Study of the BRAF Inhibitor Dabrafenib in Combination With the MEK Inhibitor Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection.
This is a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E / K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma will be screened for eligibility. Subjects will be randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.
- 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 > 5 years.
- History or current evidence of cardiovascular risk.
- History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
Locations & Contacts
Trial Phase & Type
Novartis Pharmaceuticals Corporation
Secondary IDs NCI-2013-01043
Clinicaltrials.gov ID NCT01682083