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
Participants with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist
Participants must be naïve to treatment for locally advanced unresectable or metastatic disease (ie, no prior systemic anti-cancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed
Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test
Measurable disease per RECIST v1.1
Eastern Clinical Oncology Group performance status of 0 or 1
Consent to provide archival for biomarker analyses
Consent to undergo tumor biopsies for biomarker analyses
Life expectancy greater than or equal to (≥) 12 weeks
Adequate hematologic and end organ function
1. All known CNS lesions have been treated with stereotactic therapy or surgery, AND
2. There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 3 weeks after radiotherapy or surgery
Current severe, uncontrolled systemic disease
History of malabsorption or other condition that would interfere with absorption of study drugs
Pregnant, lactating, or breast feeding women
You may not be if
History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Major surgery or traumatic injury within 14 days prior to first dose of study treatment
Active malignancy other than melanoma that could potentially interfere with the interpretation of efficacy measures. Participants with a previous malignancy within the past 3 years are excluded except for participants with resected basal cell carcinoma or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast
History of or evidence of retinal pathology on ophthalmological examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion, or neovascular macular degeneration
Uncontrolled glaucoma with intraocular pressure
Serum cholesterol ≥ Grade 2
Hypertriglyceridemia ≥ Grade 2
Hyperglycemia (fasting) ≥ Grade 2
History of clinically significant cardiac dysfunction
