A Phase III Randomized, 3-arm, Open Label, Multicenter Study of LGX818 Plus MEK162 and LGX818 Monotherapy Compared With Vemurafenib in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Trial status: Open for Enrollment
Why is this study being done?
A prospective, randomized, open label, multi-center, parallel group, 3-arm phase III study comparing the efficacy and safety of both, LGX818 plus MEK162 and LGX818 monotherapy, as compared to vemurafenib in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation.
A total of approximately 900 patients will be randomized 1:1:1 to one of 3 treatment arms: 1) LGX818 plus MEK162 (denoted as Combination arm), 2) LGX818 monotherapy (denoted as LGX818 arm), 3) vemurafenib.
Who is eligible to participate?
- Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC Stage IIIB, IIIC, or IV)
- Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
- Naïve untreated patients for unresectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy or radiotherapy)
- 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
- Any active/non-stable brain lesion
- Non-cutaneous 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 anti-cancer treatment, extensive radiotherapy or investigational agent for locally advanced unresectable or metastatic melanoma; prior systematic treatment in adjuvant setting (including ipilimumab) is allowed
- 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 or gastrointestinal disease
- 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