BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be randomized to receive oral doses of vemurafenib 960 milligrams (mg) twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.
- Histologically confirmed melanoma of cutaneous origin
- Surgically rendered free of disease within 90 days of randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 5 years
- Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
- Adequate hematologic, hepatic, and renal function
- History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
- History of limb perfusion therapy
- History of radiotherapy for the treatment of melanoma
- Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
- Family history of inherited colon cancer syndromes
- History of clinically significant cardiac or pulmonary dysfunction
- Major surgical procedure within 4 weeks prior to first dose of study treatment
- Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
Locations & Contacts
Trial Phase & Type
Secondary IDs NCI-2012-03085, G027826, 2011-004011-24
Clinicaltrials.gov ID NCT01667419
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