Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04607421 · OUTCOME

SLI: ORR 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until documented PD, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 33.9 months)

What was measured

ORR: percentage of participants who achieved BOR of confirmed CR/PR per RECIST v1.1 as assessed by response reported by investigator on eCRF. CR: complete disappearance of all target lesions (with exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10 mm. PR: \>=30% decrease under baseline of sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Percentage of participants with ORR for first line (no prior treatment) and second line (participant received prior treatment viz. advanced/metastatic or locoregional disease or maintenance or if neoadjuvant/adjuvant with a disease recurrence occurred during or within 6 months of last therapy dose) is presented.

Analysis population: The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "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]30
SLI: Cohort 2 [EC + mFOLFOX6]27

Reported measurements

First Line Treatment

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]12
SLI: Cohort 2 [EC + mFOLFOX6]19
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]75.0Not reported46.891.1Not reported
SLI: Cohort 2 [EC + mFOLFOX6]68.4Not reported46.084.6Not reported
Second Line Treatment

Analysis denominator · Participants

GroupSource count
SLI: Cohort 1 [EC + FOLFIRI]18
SLI: Cohort 2 [EC + mFOLFOX6]8
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SLI: Cohort 1 [EC + FOLFIRI]61.1Not reported38.679.7Not reported
SLI: Cohort 2 [EC + mFOLFOX6]50.0Not reported21.578.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.8
        upper Limit
        91.1
        value
        75.0
      2. group Id
        OG001
        lower Limit
        46.0
        upper Limit
        84.6
        value
        68.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    First Line Treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.6
        upper Limit
        79.7
        value
        61.1
      2. group Id
        OG001
        lower Limit
        21.5
        upper Limit
        78.5
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Second Line Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      27
    units
    Participants
description
ORR: percentage of participants who achieved BOR of confirmed CR/PR per RECIST v1.1 as assessed by response reported by investigator on eCRF. CR: complete disappearance of all target lesions (with exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis \<10 mm. PR: \>=30% decrease under baseline of sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Percentage of participants with ORR for first line (no prior treatment) and second line (participant received prior treatment viz. advanced/metastatic or locoregional disease or maintenance or if neoadjuvant/adjuvant with a disease recurrence occurred during or within 6 months of last therapy dose) is presented.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "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 randomization until documented PD, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 33.9 months)
title
SLI: ORR as Assessed by Investigator According to Line of Therapy - FAS
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice