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NCT04099251 · FLOW

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Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma · Source last updated 2026-08-07

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

groups
  1. description
    Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    FG000
    title
    Nivolumab
  2. description
    Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        526
      2. group Id
        FG001
        num Subjects
        264
      comment
      Started=randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        524
      2. group Id
        FG001
        num Subjects
        264
      comment
      Completed=treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        7
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        41
      type
      Disease recurrence
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        7
      type
      Study drug toxicity
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer meets study criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    9. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    10. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        39
      type
      Ongoing treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Maximum clinical benefit
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        524
      2. group Id
        FG001
        num Subjects
        264
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        158
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        267
      2. group Id
        FG001
        num Subjects
        106
      type
      NOT COMPLETED
    title
    Blinded Treatment Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent after re-baseline visit
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        30
      comment
      Started=Number of participants enrolled in the open-label phase Eligible participants received open-label Nivolumab treatment during a follow-up phase.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        28
      comment
      Completed=received treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Optional Open-Label Phase Pre-Treatment
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Disease progression/recurrence
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Decision by Principal Investigator
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Study drug toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        17
      type
      Ongoing treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        28
      comment
      Started=received optional open-label treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Optional Open-Label Phase Treatment
pre Assignment Details
980 participants were screened, of which 790 participants were randomized (526 nivolumab/264 placebo) into the study and 788 received either the Nivolumab treatment (524 participants) or placebo (264 participants). 30 eligible participants (2 from the Nivolumab treatment arm and 28 from the placebo arm) received open-label Nivolumab treatment during an optional open-label phase.
Complete source fields
groups
  1. description
    Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    FG000
    title
    Nivolumab
  2. description
    Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        526
      2. group Id
        FG001
        num Subjects
        264
      comment
      Started=randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        524
      2. group Id
        FG001
        num Subjects
        264
      comment
      Completed=treated
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        7
      type
      Other reasons
    2. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        41
      type
      Disease recurrence
    3. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse event unrelated to study drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        7
      type
      Study drug toxicity
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer meets study criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    9. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant request to discontinue study treatment
    10. reasons
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        39
      type
      Ongoing treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Maximum clinical benefit
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        524
      2. group Id
        FG001
        num Subjects
        264
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        257
      2. group Id
        FG001
        num Subjects
        158
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        267
      2. group Id
        FG001
        num Subjects
        106
      type
      NOT COMPLETED
    title
    Blinded Treatment Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent after re-baseline visit
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        30
      comment
      Started=Number of participants enrolled in the open-label phase Eligible participants received open-label Nivolumab treatment during a follow-up phase.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        28
      comment
      Completed=received treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Optional Open-Label Phase Pre-Treatment
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Disease progression/recurrence
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Decision by Principal Investigator
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Study drug toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        17
      type
      Ongoing treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        28
      comment
      Started=received optional open-label treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Optional Open-Label Phase Treatment
pre Assignment Details
980 participants were screened, of which 790 participants were randomized (526 nivolumab/264 placebo) into the study and 788 received either the Nivolumab treatment (524 participants) or placebo (264 participants). 30 eligible participants (2 from the Nivolumab treatment arm and 28 from the placebo arm) received open-label Nivolumab treatment during an optional open-label phase.

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Preserved source evidence · Not medical advice