Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03036098 · FLOW

Participant flow

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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

groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    FG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    FG001
    title
    Treatment 2
  3. description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    FG002
    title
    Treatment 3
  4. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    FG003
    title
    Treatment 4
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Other Reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Participant No Longer Meets Study Criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant Request to Discontinue Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        349
      2. group Id
        FG001
        num Subjects
        357
      3. group Id
        FG002
        num Subjects
        304
      4. group Id
        FG003
        num Subjects
        304
      comment
      Started = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        345
      2. comment
        13 participants were randomized to Treatment 2; however, they received the sub-study treatment (Treatment 4)
        group Id
        FG001
        num Subjects
        338
      3. group Id
        FG002
        num Subjects
        304
      4. comment
        3 participants were randomized to Treatment 4; however, they received the primary study treatment (Treatment 2)
        group Id
        FG003
        num Subjects
        291
      comment
      Completed = Treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        50
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        22
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        14
      type
      Adverse Event Unrelated to Study Drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        18
      type
      Participant Request to Discontinue Study Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        10
      type
      Maximum Clinical Benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Poor/Non Compliance
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant No Longer Meets Study Criteria
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Administrative Reason by Sponsor
    11. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        8
      type
      Other Reasons
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        0
      type
      Ongoing Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        345
      2. group Id
        FG001
        num Subjects
        325
      3. group Id
        FG002
        num Subjects
        304
      4. group Id
        FG003
        num Subjects
        288
      comment
      Started = Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        13 participants were randomized in primary study (Treatment 2); however, they received the sub-study treatment (Treatment 4)
        group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        3 participants were randomized in sub-study (Treatment 4); however, they received the primary study treatment (Treatment 2)
        group Id
        FG003
        num Subjects
        3
      type
      Received Different Treatment Than Originally Assigned
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        149
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        157
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        176
      3. group Id
        FG002
        num Subjects
        275
      4. group Id
        FG003
        num Subjects
        131
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
The study was conducted as a primary study and a sub-study. In the primary study, 706 participants were randomized, and 673 participants received treatment. Of these 673 treated participants, 3 were randomized in the sub-study. In the sub-study, 608 participants were randomized, and 605 participants received treatment. Of these 605 treated participants, 13 were randomized in the primary study.
Complete source fields
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    FG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    FG001
    title
    Treatment 2
  3. description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    FG002
    title
    Treatment 3
  4. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    FG003
    title
    Treatment 4
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Other Reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      type
      Participant No Longer Meets Study Criteria
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant Request to Discontinue Study Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        349
      2. group Id
        FG001
        num Subjects
        357
      3. group Id
        FG002
        num Subjects
        304
      4. group Id
        FG003
        num Subjects
        304
      comment
      Started = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        345
      2. comment
        13 participants were randomized to Treatment 2; however, they received the sub-study treatment (Treatment 4)
        group Id
        FG001
        num Subjects
        338
      3. group Id
        FG002
        num Subjects
        304
      4. comment
        3 participants were randomized to Treatment 4; however, they received the primary study treatment (Treatment 2)
        group Id
        FG003
        num Subjects
        291
      comment
      Completed = Treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        168
      4. group Id
        FG003
        num Subjects
        50
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        45
      3. group Id
        FG002
        num Subjects
        26
      4. group Id
        FG003
        num Subjects
        22
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        14
      type
      Adverse Event Unrelated to Study Drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        18
      type
      Participant Request to Discontinue Study Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        10
      type
      Maximum Clinical Benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Poor/Non Compliance
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Participant No Longer Meets Study Criteria
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      type
      Administrative Reason by Sponsor
    11. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        8
      type
      Other Reasons
    12. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        23
      4. group Id
        FG003
        num Subjects
        0
      type
      Ongoing Treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        345
      2. group Id
        FG001
        num Subjects
        325
      3. group Id
        FG002
        num Subjects
        304
      4. group Id
        FG003
        num Subjects
        288
      comment
      Started = Treated
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        13 participants were randomized in primary study (Treatment 2); however, they received the sub-study treatment (Treatment 4)
        group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        0
      4. comment
        3 participants were randomized in sub-study (Treatment 4); however, they received the primary study treatment (Treatment 2)
        group Id
        FG003
        num Subjects
        3
      type
      Received Different Treatment Than Originally Assigned
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        149
      3. group Id
        FG002
        num Subjects
        29
      4. group Id
        FG003
        num Subjects
        157
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        176
      3. group Id
        FG002
        num Subjects
        275
      4. group Id
        FG003
        num Subjects
        131
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
The study was conducted as a primary study and a sub-study. In the primary study, 706 participants were randomized, and 673 participants received treatment. Of these 673 treated participants, 3 were randomized in the sub-study. In the sub-study, 608 participants were randomized, and 605 participants received treatment. Of these 605 treated participants, 13 were randomized in the primary study.

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

Preserved source evidence · Not medical advice