Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04607421 · OUTCOME

SLI: Time to Response (TTR) as Assessed by Investigator According to Line of Therapy - FAS

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

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

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
Full Range
Time frame
From date of first dose to first radiographic evidence of response (CR or PR) (maximum up to 33.9 months [147.3 weeks])

What was measured

TTR was defined as the time from the date of first dose to first radiographic evidence of response (CR or PR) per RECIST v1.1 as assessed by response reported by investigator on eCRF. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. In this outcome measure, TTR for first line (no prior treatment) and second line (participant received a prior treatment defined as advanced/metastatic or locoregional disease or maintenance or if neoadjuvant/adjuvant with a disease recurrence occurred during or within 6 months of the last dose of therapy) were reported.

Analysis population: The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response as assessed by investigator and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.

Groups in this outcome

SLI: Cohort 1 [EC + FOLFIRI]

Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.

SLI: Cohort 2 [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

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

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]20
SLI: Cohort 2 [EC + mFOLFOX6]17

Reported measurements

First Line Treatment

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]9
SLI: Cohort 2 [EC + mFOLFOX6]13
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]6.6Not reported6.194.1Not reported
SLI: Cohort 2 [EC + mFOLFOX6]6.9Not reported5.925.9Not reported
Second Line Treatment

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]11
SLI: Cohort 2 [EC + mFOLFOX6]4
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]12.9Not reported6.137.0Not reported
SLI: Cohort 2 [EC + mFOLFOX6]9.4Not reported6.418.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        94.1
        value
        6.6
      2. group Id
        OG001
        lower Limit
        5.9
        upper Limit
        25.9
        value
        6.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    First Line Treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        37.0
        value
        12.9
      2. group Id
        OG001
        lower Limit
        6.4
        upper Limit
        18.9
        value
        9.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Second Line Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      17
    units
    Participants
description
TTR was defined as the time from the date of first dose to first radiographic evidence of response (CR or PR) per RECIST v1.1 as assessed by response reported by investigator on eCRF. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. In this outcome measure, TTR for first line (no prior treatment) and second line (participant received a prior treatment defined as advanced/metastatic or locoregional disease or maintenance or if neoadjuvant/adjuvant with a disease recurrence occurred during or within 6 months of the last dose of therapy) were reported.
dispersion Type
Full Range
groups
  1. description
    Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    SLI: Cohort 1 [EC + FOLFIRI]
  2. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG001
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
param Type
MEDIAN
population Description
The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response as assessed by investigator and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
reporting Status
POSTED
time Frame
From date of first dose to first radiographic evidence of response (CR or PR) (maximum up to 33.9 months [147.3 weeks])
title
SLI: Time to Response (TTR) as Assessed by Investigator According to Line of Therapy - FAS
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice