A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.
Inclusion Criteria:
Exclusion Criteria:
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
Participants with active central nervous system (CNS) lesions (including carcinomatous meningitis) are excluded. However, participants are eligible if:
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
Louisville, Kentucky 40202, United States
St Louis, Missouri 63108, United States
Lebanon, New Hampshire 03756, United States
Woolloongabba, New South Wales 2050, Australia
Ashford SA, South Australia 5035, Australia
Prahan, Victoria 3181, Australia
London, Quebec N6A 4G5, Canada
Ostrava - Poruba, 708 52, Czechia
Kiel, 24105, Germany
Meldola, Emilia-Romagna 47014, Italy
Bergamo, Lombardy 24127, Italy