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NCT01682083 · OUTCOME

Freedom From Relapse (FFR)

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Approximately 4 years

What was measured

Freedom from relapse (FFR) was defined as the interval from randomization to local or distant recurrence with censoring of patients dying from causes other than melanoma or treatment -related toxicity at the date of death. The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death.

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
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dabrafenib and Trametinib Combination TherapyNANot reported44.5NAN/A: Not Estimable due to number of events censored
Dabrafenib and Trametinib Placebos16.6Not reported12.722.3Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.57
    group Description
    Hazard ratio is estimated using Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.
    non Inferiority Type
    SUPERIORITY
    p Value
    <.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.47
    statistical Comment
    Hazard Ratio and p-value from stratified log-rank test are adjusted for randomized strata: Disease Stage and BRAF mutation status.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.57
    group Description
    Hazard ratio is estimated using Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.
    non Inferiority Type
    SUPERIORITY
    p Value
    <.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.47
    statistical Comment
    Hazard Ratio and p-value from stratified log-rank test are adjusted for randomized strata: Disease Stage and BRAF mutation status.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        N/A: Not Estimable due to number of events censored
        group Id
        OG000
        lower Limit
        44.5
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        12.7
        upper Limit
        22.3
        value
        16.6
denoms
  1. counts
    1. group Id
      OG000
      value
      438
    2. group Id
      OG001
      value
      432
    units
    Participants
description
Freedom from relapse (FFR) was defined as the interval from randomization to local or distant recurrence with censoring of patients dying from causes other than melanoma or treatment -related toxicity at the date of death. The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death.
dispersion Type
Full Range
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
MEDIAN
population Description
Intent-to-Treat (ITT) Population
reporting Status
POSTED
time Frame
Approximately 4 years
title
Freedom From Relapse (FFR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice