Multiple Myeloma Clinical Trial
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Summary
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.
Part 1:
Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:
LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
vemurafenib 960 mg BID (denoted as vemurafenib arm)
Part 2:
Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:
LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
LGX818 300 mg QD monotherapy (denoted as LGX818 arm)
Eligibility Criteria
Inclusion Criteria:
Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), except the administration of BRAF or MEK inhibitors
Evidence of at least one measurable lesion as detected by radiological or photographic methods
ECOG performance status of 0 or 1
Adequate bone marrow, organ function, cardiac and laboratory parameters
Normal functioning of daily living activities
Exclusion Criteria:
Any untreated central nervous system (CNS) lesion
Uveal and mucosal melanoma
History of leptomeningeal metastases
History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
History of Gilbert's syndrome
Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
Impaired cardiovascular function or clinically significant cardiovascular diseases
Uncontrolled arterial hypertension despite medical treatment
HIV positive or active Hepatitis B, and/or active Hepatitis C
Impairment of gastrointestinal function
Patients with neuromuscular disorders that are associated with elevated CK
Pregnant or nursing (lactating) women
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Other protocol-defined inclusion/exclusion criteria may apply
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