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NCT04008030 · BASELINE

Baseline characteristics

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) · Source last updated 2026-08-20

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
      353
    2. group Id
      BG001
      value
      354
    3. group Id
      BG002
      value
      132
    4. group Id
      BG003
      value
      839
    units
    Participants
groups
  1. description
    Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    BG000
    title
    Arm A - Nivolumab Monotherapy
  2. description
    Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    BG001
    title
    Arm B - Nivolumab + Ipilimumab
  3. description
    Participants received standard of care chemotherapy
    id
    BG002
    title
    Arm C - Investigator's Choice Chemotherapy
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.76
          value
          60.3
        2. group Id
          BG001
          spread
          13.14
          value
          60.5
        3. group Id
          BG002
          spread
          14.93
          value
          61.3
        4. group Id
          BG003
          spread
          13.69
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          423
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          416
        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
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          77
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          421
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          341
        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
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          78
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          311
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          729
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          19
        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
      353
    2. group Id
      BG001
      value
      354
    3. group Id
      BG002
      value
      132
    4. group Id
      BG003
      value
      839
    units
    Participants
groups
  1. description
    Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    BG000
    title
    Arm A - Nivolumab Monotherapy
  2. description
    Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    BG001
    title
    Arm B - Nivolumab + Ipilimumab
  3. description
    Participants received standard of care chemotherapy
    id
    BG002
    title
    Arm C - Investigator's Choice Chemotherapy
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.76
          value
          60.3
        2. group Id
          BG001
          spread
          13.14
          value
          60.5
        3. group Id
          BG002
          spread
          14.93
          value
          61.3
        4. group Id
          BG003
          spread
          13.69
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          423
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          416
        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
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          77
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          189
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          421
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          341
        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
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          78
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          311
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          729
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          19
        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 · Independent clinical review pending · Not medical advice