Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Public ClinicalTrials.gov record NCT01909453. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01909453
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 921 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2013 (Actual)
- Primary completion
- Nov 9, 2016 (Actual)
- Completion
- Sep 3, 2024 (Actual)
- Last update posted
- Feb 27, 2026
2013 – 2024
United States locations
- U.S. sites
- 50
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Consultants of Alabama P.C. | Birmingham | Alabama | 35233 | — |
| UAB Callahan Eye Hospital | Birmingham | Alabama | 35233 | — |
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35233 | — |
| UAB The Kirklin Clinic | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35243 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Oncology Associates | Tucson | Arizona | 85710 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | — |
| Highlands Oncology Group - Fayetteville | Springdale | Arkansas | 72762 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| Rocky Mountain Cancer Centers (Williams) - USOR | Aurora | Colorado | 80012 | — |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | — |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | — |
| Rocky Mountain Cancer Centers (Williams) - USOR | Denver | Colorado | 80218 | — |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | — |
| Specialty Eye Care | Parker | Colorado | 80134 | — |
| Rocky Mountain Cancer Centers | Pueblo | Colorado | 81008 | — |
| University Cancer Institute | Boynton Beach | Florida | 33426 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Eye & Ear Infirmary- Opthalmology | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Sciences System - Investigational Drug Service | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | — |
| University of Illinois Medical Center | Chicago | Illinois | 60612 | — |
| Oncology Specialists, SC | Niles | Illinois | 60714 | — |
| Goshen Center For Cancer Care | Goshen | Indiana | 46526 | — |
| Lack's Cancer Center at Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | — |
| Mercy Health Hauenstein Neuroscience Center Neuro-Ophthalmology (Clinic) | Grand Rapids | Michigan | 49503 | — |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49525 | — |
| Hattiesburg Clinic Oncology Hem | Hattiesburg | Mississippi | 39401 | — |
| Jackson Oncology Associates - St. Dominic Hospital | Jackson | Mississippi | 39202 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Investigational Drug Service, Department of Pharmacy (Investigational Product) | Rochester | New York | 14642 | — |
| University of Rochester Medical Center - PPDS | Rochester | New York | 14642 | — |
| Tulsa Cancer Institute PLLC | Tulsa | Oklahoma | 74146 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Sanford Cancer Center Oncology Clinic & Pharmacy | Sioux Falls | South Dakota | 57104 | — |
| University of Tennessee Medical Center Cancer Institute | Knoxville | Tennessee | 37920 | — |
| Dr. Dennis B. Kay (Ophthalmologist) | Dallas | Texas | 75231 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Virginia Cancer Specialists, PC | Alexandria | Virginia | 22304 | — |
| Virginia Cancer Specialists | Arlington | Virginia | 22205 | — |
| Virginia Cancer Specialists (Leesburg) - USOR | Fairfax | Virginia | 22031 | — |
| Northern Virginia Ophthalmology Associates | Falls Church | Virginia | 22044 | — |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | 20155 | — |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 232 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01909453, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01909453 live on ClinicalTrials.gov.