CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 921 enrolled
Drug / intervention
LGX818 +2 moredrug
Likely dose
LGX818 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01909453
NCT01909453Phase 3Completed
CompareCT.gov

A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Pfizer·interventional·Posted Jul 26, 2013·Updated Feb 27, 2026

In Brief

A Phase 3 clinical trial evaluating LGX818, MEK162, and 1 other intervention for Melanoma. Completed, enrolled 921 participants across 282 sites in 29 countries.

Detailed 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: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. 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: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Australia, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 26, 2013
Enrollment StartSep 12, 2013
Primary CompletionNov 9, 2016
Study CompletionSep 3, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.9 years ago

Interventions

LGX818drug

LGX818- Orally 100 mg and 50 mg capsules

MEK162drug

MEK162- Orally 15 mg tablets

vemurafenibdrug

Tablets in bottles or blisters 240 mg