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NCT01844505 · FLOW

Participant flow

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) · Source last updated 2025-05-21

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

groups
  1. description
    Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
    id
    FG000
    title
    Nivolumab
  2. description
    Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
    id
    FG001
    title
    Nivolumab + Ipilimumab
  3. description
    Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
    id
    FG002
    title
    Ipilimumab
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        314
      3. group Id
        FG002
        num Subjects
        315
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        19
      type
      SUBJECT WITHDREW CONSENT
    2. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        136
      3. group Id
        FG002
        num Subjects
        58
      type
      Other Reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        6
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        175
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        228
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      type
      NOT COMPLETED
    title
    Treatment Period
Complete source fields
groups
  1. description
    Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
    id
    FG000
    title
    Nivolumab
  2. description
    Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
    id
    FG001
    title
    Nivolumab + Ipilimumab
  3. description
    Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
    id
    FG002
    title
    Ipilimumab
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        314
      3. group Id
        FG002
        num Subjects
        315
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Pre-Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        19
      type
      SUBJECT WITHDREW CONSENT
    2. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        136
      3. group Id
        FG002
        num Subjects
        58
      type
      Other Reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        6
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        175
      2. group Id
        FG001
        num Subjects
        154
      3. group Id
        FG002
        num Subjects
        228
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        313
      2. group Id
        FG001
        num Subjects
        313
      3. group Id
        FG002
        num Subjects
        311
      type
      NOT COMPLETED
    title
    Treatment Period

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Preserved source evidence · Not medical advice