Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

PHASE3CompletedINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

January 8, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

July 31, 2023

Conditions
Melanoma
Interventions
DRUG

Dabrafenib

Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)

DRUG

Trametinib

Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

DRUG

Placebos

The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment

Trial Locations (210)

100

Novartis Investigative Site, Taipei

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Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY