Participant flow

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). · Source last updated 2026-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

   id

   FG000

   title

   Dabrafenib and Trametinib Combination Therapy

2. description

   Subjects received matching placebos orally for 12 months

   id

   FG001

   title

   Dabrafenib and Trametinib Placebos

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         125

      2. group Id

         FG001

         num Subjects

         136

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         225

      2. group Id

         FG001

         num Subjects

         192

      type

      Study closed by sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         43

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         8

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         53

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         438

      2. group Id

         FG001

         num Subjects

         432

      comment

      All randomized patients are included in the Intent-to-Treat Population (ITT) regardless of whether or not they received study treatment.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Untreated

   3. achievements

      1. group Id

         FG000

         num Subjects

         435

      2. group Id

         FG001

         num Subjects

         432

      comment

      All patients who received at least one dose of randomized treatment.

      type

      Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         438

      2. group Id

         FG001

         num Subjects

         432

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc).

recruitment Details

The study was conducted in 169 centers across 25 countries.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice