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NCT02928224 · OUTCOME

(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)

What was measured

PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.

Groups in this outcome

Phase 3: Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Phase 3:Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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

Analysis denominator · Participants

GroupSource count
Phase 3: Doublet Arm220
Phase 3:Control Arm221

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 3: Doublet Arm4.21Not reported3.715.36Not reported
Phase 3:Control Arm1.51Not reported1.451.71Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Stratified Log-rank
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Method
    Stratified Log-rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.71
        upper Limit
        5.36
        value
        4.21
      2. group Id
        OG001
        lower Limit
        1.45
        upper Limit
        1.71
        value
        1.51
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      221
    units
    Participants
description
PFS was defined as the time from first dose to the earliest documented PD or death due to any cause. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    OG000
    title
    Phase 3: Doublet Arm
  2. description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    OG001
    title
    Phase 3:Control Arm
param Type
MEDIAN
population Description
The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.
reporting Status
POSTED
time Frame
From first dose to the earliest documented PD or death due to any cause (maximum treatment exposure of 268 weeks for doublet arm and 108 weeks for control arm)
title
(Phase 3) Comparison of Progression-Free Survival (PFS) in Doublet Arm vs Control Arm Per BICR
type
SECONDARY
unit Of Measure
Months

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