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NCT04607421 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      30
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      158
    4. group Id
      BG003
      value
      236
    5. group Id
      BG004
      value
      243
    6. group Id
      BG005
      value
      73
    7. group Id
      BG006
      value
      74
    8. group Id
      BG007
      value
      841
    units
    Participants
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
    BG000
    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
    BG001
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
  3. 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
    BG002
    title
    Phase 3: Arm A [EC]
  4. 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
    BG003
    title
    Phase 3: Arm B [EC + mFOLFOX6]
  5. 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
    BG004
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
  6. 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    BG005
    title
    Cohort 3: Arm D [EC + FOLFIRI]
  7. description
    Participants received 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 with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
    id
    BG006
    title
    Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          150
        5. group Id
          BG004
          value
          139
        6. group Id
          BG005
          value
          37
        7. group Id
          BG006
          value
          46
        8. group Id
          BG007
          value
          515
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          104
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          326
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          124
        6. group Id
          BG005
          value
          40
        7. group Id
          BG006
          value
          39
        8. group Id
          BG007
          value
          421
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          123
        5. group Id
          BG004
          value
          119
        6. group Id
          BG005
          value
          33
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          420
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          98
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          131
        4. group Id
          BG003
          value
          187
        5. group Id
          BG004
          value
          201
        6. group Id
          BG005
          value
          58
        7. group Id
          BG006
          value
          64
        8. group Id
          BG007
          value
          686
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          57
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          91
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          306
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          141
        5. group Id
          BG004
          value
          144
        6. group Id
          BG005
          value
          41
        7. group Id
          BG006
          value
          49
        8. group Id
          BG007
          value
          505
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      30
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      158
    4. group Id
      BG003
      value
      236
    5. group Id
      BG004
      value
      243
    6. group Id
      BG005
      value
      73
    7. group Id
      BG006
      value
      74
    8. group Id
      BG007
      value
      841
    units
    Participants
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
    BG000
    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
    BG001
    title
    SLI: Cohort 2 [EC + mFOLFOX6]
  3. 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
    BG002
    title
    Phase 3: Arm A [EC]
  4. 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
    BG003
    title
    Phase 3: Arm B [EC + mFOLFOX6]
  5. 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
    BG004
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
  6. 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    BG005
    title
    Cohort 3: Arm D [EC + FOLFIRI]
  7. description
    Participants received 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 with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
    id
    BG006
    title
    Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          105
        4. group Id
          BG003
          value
          150
        5. group Id
          BG004
          value
          139
        6. group Id
          BG005
          value
          37
        7. group Id
          BG006
          value
          46
        8. group Id
          BG007
          value
          515
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          53
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          104
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          28
        8. group Id
          BG007
          value
          326
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          124
        6. group Id
          BG005
          value
          40
        7. group Id
          BG006
          value
          39
        8. group Id
          BG007
          value
          421
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          123
        5. group Id
          BG004
          value
          119
        6. group Id
          BG005
          value
          33
        7. group Id
          BG006
          value
          35
        8. group Id
          BG007
          value
          420
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          98
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          131
        4. group Id
          BG003
          value
          187
        5. group Id
          BG004
          value
          201
        6. group Id
          BG005
          value
          58
        7. group Id
          BG006
          value
          64
        8. group Id
          BG007
          value
          686
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          57
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          91
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          306
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          88
        4. group Id
          BG003
          value
          141
        5. group Id
          BG004
          value
          144
        6. group Id
          BG005
          value
          41
        7. group Id
          BG006
          value
          49
        8. group Id
          BG007
          value
          505
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice