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NCT02060188 · FLOW

Participant flow

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread · Source last updated 2025-11-06

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

groups
  1. description
    Nivolumab 3 mg/kg
    id
    FG000
    title
    Cohort 1: Nivolumab Monotherapy
  2. description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
    id
    FG001
    title
    Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
  3. description
    Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
    id
    FG002
    title
    Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
  4. description
    Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
    id
    FG003
    title
    MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
  5. description
    Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
    id
    FG004
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
  6. description
    Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
    id
    FG005
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
  7. description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
    id
    FG006
    title
    Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
  8. description
    Nivolumab 240 mg + BMS-986016 80 mg
    id
    FG007
    title
    Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
  9. description
    Nivolumab FD + Daratumumab 16 mg/kg
    id
    FG008
    title
    Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        23
      8. group Id
        FG007
        num Subjects
        20
      9. group Id
        FG008
        num Subjects
        43
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        0
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        19
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        0
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        0
      type
      Other reason
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Administrative reasons by sponsor
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        50
      9. group Id
        FG008
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        50
      9. group Id
        FG008
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Nivolumab 3 mg/kg
    id
    FG000
    title
    Cohort 1: Nivolumab Monotherapy
  2. description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
    id
    FG001
    title
    Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
  3. description
    Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
    id
    FG002
    title
    Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
  4. description
    Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
    id
    FG003
    title
    MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
  5. description
    Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
    id
    FG004
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
  6. description
    Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
    id
    FG005
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
  7. description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
    id
    FG006
    title
    Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
  8. description
    Nivolumab 240 mg + BMS-986016 80 mg
    id
    FG007
    title
    Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
  9. description
    Nivolumab FD + Daratumumab 16 mg/kg
    id
    FG008
    title
    Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        23
      8. group Id
        FG007
        num Subjects
        20
      9. group Id
        FG008
        num Subjects
        43
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        0
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        19
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        0
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        0
      type
      Other reason
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      type
      Death
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Administrative reasons by sponsor
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        50
      9. group Id
        FG008
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        119
      3. group Id
        FG002
        num Subjects
        45
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        10
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        30
      8. group Id
        FG007
        num Subjects
        50
      9. group Id
        FG008
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Independent clinical review pending · Not medical advice