A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01584648

Run by

Novartis Pharmaceuticals

People needed

423

Starts

2012-05-04

Expected to finish

2019-02-28

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible.
• The subject must have a radiologically measurable tumor
• The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
• Able to swallow and retain oral medication
• Sexually active subjects must use acceptable methods of contraception during the course of the study
• Adequate organ system function and blood counts

You may not qualify if…

• Prior treatment with a BRAF or a MEK inhibitor
• Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
• The subject has received major surgery or certain tyes of cancer therapy with 21 days of starting treatment
• Current use of prohibited medication listed in the protocol
• Left ventricular ejection fraction less than the lower limit of normal
• Uncontrolled blood pressurl
• History or current evidence of retinal vein occlusion or central serous retinopathy
• Brain metastases unless previously treated with surgery or stereotactic radiosurgery and the disease has been stable for at least 12 weeks
• The subject is pregnant or nursing

Where it is running

• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Fort Myers, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Peoria, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Columbia, South Carolina, United States
• Novartis Investigative Site — Chattanooga, Tennessee, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — Richmond, Virginia, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — North Sydney, New South Wales, Australia
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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