A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
Public ClinicalTrials.gov record NCT01584648. 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 Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy 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, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.
Study identification
- NCT ID
- NCT01584648
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 423 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
- May 3, 2012
- Primary completion
- Aug 25, 2013
- Completion
- Feb 27, 2019
- Last update posted
- Feb 16, 2021
2012 – 2019
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Scottsdale | Arizona | 85258 | — |
| Novartis Investigative Site | Tucson | Arizona | 85719 | — |
| Novartis Investigative Site | Los Angeles | California | 90024 | — |
| Novartis Investigative Site | Fort Myers | Florida | 33916 | — |
| Novartis Investigative Site | St. Petersburg | Florida | 33705 | — |
| Novartis Investigative Site | Tampa | Florida | 33612 | — |
| Novartis Investigative Site | West Palm Beach | Florida | 33401 | — |
| Novartis Investigative Site | Peoria | Illinois | 61615-7822 | — |
| Novartis Investigative Site | Indianapolis | Indiana | 46202 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | — |
| Novartis Investigative Site | New York | New York | 10065 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29210 | — |
| Novartis Investigative Site | Chattanooga | Tennessee | 37404 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | — |
| Novartis Investigative Site | Richmond | Virginia | 23230 | — |
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 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01584648, 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 16, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01584648 live on ClinicalTrials.gov.