Status and phase
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About
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.
Enrollment
Sex
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Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
495 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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