Vemurafenib + Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib

Inclusion Criteria: * Histologically confirmed melanoma harboring the V600 mutation * Unresectable Stage IV melanoma * At least 18 y of age * Eastern Cooperative Oncology Group (ECOG) performance status of \<2 * In progression during treatment with Vemurafenib * At least 2 weeks since the last radiotherapy treatment * Life expectancy \>12 weeks * Clinical laboratory values at screening defined as follow: lactate dehydrogenase (LDH) \< 2.0 x upper limit of normal (ULN), Hemoglobin \>9 g/dL, Absolute neutrophil count 1500/mm3, Platelet count \>100,000/mm3, Creatinine \<1.5 mg/dL (NOTE: If creatinine is \>1.5 mg/dL, subject is eligible if creatinine clearance \> 60 mL/min using the Cockgroft-Gault equation), Total bilirubin \<1.5 x ULN, Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \<2.5 x ULN * Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year * Fertile men and women must use an effective method of contraception * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Female subjects who are pregnant or nursing * Female subjects of childbearing potential or males not using or not willing to use two forms of effective contraception * Any of the following within the 6 months prior to randomization: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications * Concurrent administration of any anti-cancer therapies (e.g. chemotherapy, other targeted therapy, experimental drug, etc) other than those administered in this study * Known hypersensitivity to Vemurafenib or another BRAF inhibitor * History of congenital long QT syndrome, history or presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2 (NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 * Corrected QT (QTc) interval ≥ 500 msec at baseline * Uncontrolled medical illness (such as infection requiring treatment with intravenous (IV) antibiotics) * Has had surgery within 2 weeks (1 week for minor surgery, eg, procedures requiring only local anesthetics) prior to the first dose of study medication