Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01682083 · OUTCOME

Percentage of Participants With Relapse-free Survival (RFS) Events

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Approximately 4 years

What was measured

Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.

Analysis population: Intent-to-Treat (ITT) Population

Groups in this outcome

Dabrafenib and Trametinib Combination Therapy

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

Dabrafenib and Trametinib Placebos

Subjects received matching placebos orally for 12 months

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dabrafenib and Trametinib Combination Therapy438
Dabrafenib and Trametinib Placebos432

Reported measurements

Source class 1

Relapsed (event)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy163Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos247Not reportedNot reportedNot reportedNot reported

Died (event)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy3Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos1Not reportedNot reportedNot reportedNot reported

Censored, follow-up ended at the time of Primary Completion Date

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy43Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos35Not reportedNot reportedNot reportedNot reported

Censored, follow-up ongoing at the time of Primary Completion Date

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination Therapy229Not reportedNot reportedNot reportedNot reported
Dabrafenib and Trametinib Placebos149Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        247
      title
      Relapsed (event)
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      title
      Died (event)
    3. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        35
      title
      Censored, follow-up ended at the time of Primary Completion Date
    4. measurements
      1. group Id
        OG000
        value
        229
      2. group Id
        OG001
        value
        149
      title
      Censored, follow-up ongoing at the time of Primary Completion Date
denoms
  1. counts
    1. group Id
      OG000
      value
      438
    2. group Id
      OG001
      value
      432
    units
    Participants
description
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
groups
  1. description
    Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
    id
    OG000
    title
    Dabrafenib and Trametinib Combination Therapy
  2. description
    Subjects received matching placebos orally for 12 months
    id
    OG001
    title
    Dabrafenib and Trametinib Placebos
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-Treat (ITT) Population
reporting Status
POSTED
time Frame
Approximately 4 years
title
Percentage of Participants With Relapse-free Survival (RFS) Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice