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NCT01597908 · OUTCOME

Progression-Free Survival (PFS), as Assessed by the Investigator

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma · Source last updated 2021-02-24

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)

What was measured

Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

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

Groups in this outcome

Dabrafenib Plus Trametinib

Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.

Vemurafenib

Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.

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 Plus Trametinib352
Vemurafenib352

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dabrafenib Plus Trametinib12.1Not reported9.714.7Not reported
Vemurafenib7.3Not reported6.08.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    estimate Comment
    Hazard ratios are estimated using a Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
Complete source fields
analyses
  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    estimate Comment
    Hazard ratios are estimated using a Pike estimator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.7
        upper Limit
        14.7
        value
        12.1
      2. group Id
        OG001
        lower Limit
        6.0
        upper Limit
        8.1
        value
        7.3
denoms
  1. counts
    1. group Id
      OG000
      value
      352
    2. group Id
      OG001
      value
      352
    units
    Participants
description
Progression-free survival (PFS) was defined as the interval of time between the date of randomization and the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression was defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Dabrafenib Plus Trametinib
  2. description
    Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
    id
    OG001
    title
    Vemurafenib
param Type
MEDIAN
population Description
Intent-to-Treat (ITT) Population.
reporting Status
POSTED
time Frame
From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years)
title
Progression-Free Survival (PFS), as Assessed by the Investigator
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Independent clinical review pending · Not medical advice