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Completed Phase 3 Interventional Results available

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

ClinicalTrials.gov ID: NCT01597908

Public ClinicalTrials.gov record NCT01597908. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:43 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

Study identification

NCT ID
NCT01597908
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
704 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Jun 4, 2012 (Actual)
Primary completion
Apr 17, 2014 (Actual)
Completion
Apr 25, 2019 (Actual)
Last update posted
Feb 24, 2021

2012 – 2019

United States locations

U.S. sites
36
U.S. states
23
U.S. cities
33
Facility City State ZIP Site status
Novartis Investigative Site Birmingham Alabama 35243 —
Novartis Investigative Site Gilbert Arizona 85234 —
Novartis Investigative Site Beverly Hills California 90211 —
Novartis Investigative Site San Francisco California 94115 —
Novartis Investigative Site Vallejo California 94589 —
Novartis Investigative Site Aurora Colorado 80010 —
Novartis Investigative Site Jacksonville Florida 32204 —
Novartis Investigative Site Miami Beach Florida 33140 —
Novartis Investigative Site Orlando Florida 32804 —
Novartis Investigative Site Atlanta Georgia 30322 —
Novartis Investigative Site Atlanta Georgia 30341 —
Novartis Investigative Site Iowa City Iowa 52242 —
Novartis Investigative Site Ann Arbor Michigan 48109 —
Novartis Investigative Site Fridley Minnesota 55432 —
Novartis Investigative Site St Louis Missouri 63110 —
Novartis Investigative Site Las Vegas Nevada 89148 —
Novartis Investigative Site Hackensack New Jersey 07601 —
Novartis Investigative Site New Brunswick New Jersey 08901 —
Novartis Investigative Site New York New York 10029 —
Novartis Investigative Site Chapel Hill North Carolina 27599-7600 —
Novartis Investigative Site Charlotte North Carolina 28204 —
Novartis Investigative Site Durham North Carolina 27710 —
Novartis Investigative Site Cincinnati Ohio 45219 —
Novartis Investigative Site Columbus Ohio 43210 —
Novartis Investigative Site Bend Oregon 97701 —
Novartis Investigative Site Portland Oregon 97213 —
Novartis Investigative Site Portland Oregon 97239 —
Novartis Investigative Site Charleston South Carolina 29425 —
Novartis Investigative Site Greenville South Carolina 29605 —
Novartis Investigative Site Nashville Tennessee 37232 —
Novartis Investigative Site Dallas Texas 75246 —
Novartis Investigative Site Salt Lake City Utah 84106 —
Novartis Investigative Site Salt Lake City Utah 84112-5550 —
Novartis Investigative Site Burlington Vermont 05403 —
Novartis Investigative Site Charlottesville Virginia 22903 —
Novartis Investigative Site Milwaukee Wisconsin 53226 —

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 169 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01597908, 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 24, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01597908 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →