Patient case: 64-year-old female with melanoma; genetic feature: BRAF (E586K)

Clinical trial: A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

Summary: 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 enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed melanoma of cutaneous origin
  -  Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
  -  BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
  -  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
  Exclusion Criteria:
  -  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
  -  Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
  -  History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
  -  History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
  -  History of local and/or regional and/or distant melanoma recurrence
  -  History or current radiographic or pathologic evidence of distant metastases
  -  History of clinically significant cardiac or pulmonary dysfunction
  -  Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
  -  Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus

Relevance to patient case: possibly relevant