Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04607421 · OUTCOME

Phase 3: Number of Participants Classified According to Microsatellite Instability (MSI) Status as Determined by Retrospective Central Testing of Baseline Tumor Tissue

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline

What was measured

MSI status was classified as follows; microsatellite instability-high (MSI-H): included participants with no negative test results and at least one positive test result, microsatellite stable (MSS): included participants with at least one negative test result and MSI-unknown: included participants with intermediate test results or not analyzed for MSI. The number of participants as per their MSI status (MSI-H, MSS, and MSI-unknown) have been reported in this outcome measure.

Analysis population: The biomarker tumor tissue analysis set was defined as participants from the safety analysis set who had a tumor biomarker assessment at baseline.

Groups in this outcome

Phase 3: Arm A [EC]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm B [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.

Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): 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; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.

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: Arm A [EC]153
Phase 3: Arm B [EC + mFOLFOX6]232
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]229

Reported measurements

Source class 1

MSI-H

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]1Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]1Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]1Not reportedNot reportedNot reportedNot reported

MSS

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]147Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]218Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]219Not reportedNot reportedNot reportedNot reported

MSI-Unknown

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 3: Arm A [EC]5Not reportedNot reportedNot reportedNot reported
Phase 3: Arm B [EC + mFOLFOX6]13Not reportedNot reportedNot reportedNot reported
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      title
      MSI-H
    2. measurements
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        218
      3. group Id
        OG002
        value
        219
      title
      MSS
    3. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        9
      title
      MSI-Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      232
    3. group Id
      OG002
      value
      229
    units
    Participants
description
MSI status was classified as follows; microsatellite instability-high (MSI-H): included participants with no negative test results and at least one positive test result, microsatellite stable (MSS): included participants with at least one negative test result and MSI-unknown: included participants with intermediate test results or not analyzed for MSI. The number of participants as per their MSI status (MSI-H, MSS, and MSI-unknown) have been reported in this outcome measure.
groups
  1. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    Phase 3: Arm A [EC]
  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
    Phase 3: Arm B [EC + mFOLFOX6]
  3. description
    Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): 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; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
    id
    OG002
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
param Type
COUNT_OF_PARTICIPANTS
population Description
The biomarker tumor tissue analysis set was defined as participants from the safety analysis set who had a tumor biomarker assessment at baseline.
reporting Status
POSTED
time Frame
Baseline
title
Phase 3: Number of Participants Classified According to Microsatellite Instability (MSI) Status as Determined by Retrospective Central Testing of Baseline Tumor Tissue
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice