Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants, \>/= 18 years of age
Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF V600 mutation (cobas 4800 BRAF V600 Mutation Test)
Measurable brain metastases, defined as lesions that were accurately measured in at least one dimension (longest diameter to be recorded) as ≥0.5 cm in the brain MRI with contrast, treated or untreated
Participants may or may not have received prior systemic therapy for metastatic melanoma and either a) have received no prior treatment for brain metastases or b) have received prior treatment for brain metastases and have progressed
Participants may or may not have symptoms related to their brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Participants must have recovered from all side effects of their most recent systemic or local treatment for metastatic melanoma
You may not be if
Increasing corticosteroid dose during the 7 days prior to first dose of study drug
Leptomeningeal involvement in participants with no prior treatment for brain metastases
Previous malignancy requiring active treatment within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
Concurrent administration of any anticancer therapies other than those administered in the study
Treatment with any cytotoxic, investigational drug or targeted therapy 4 weeks prior to first dose of study drug. Radiation therapy ≤1 week prior to first administration of vemurafenib; and stereotactic radiotherapy ≤1 day prior to prior to first administration of vemurafenib
Prior treatment with BRAF or MEK inhibitors
Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug
