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NCT00636168 · FLOW

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Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma · Source last updated 2019-12-17

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

groups
  1. description
    Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    FG000
    title
    Ipilimumab 10mg/kg
  2. description
    Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        475
      2. group Id
        FG001
        num Subjects
        476
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        471
      2. group Id
        FG001
        num Subjects
        474
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Randomized to Study Drug
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        282
      type
      Recurrence of disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        22
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        21
      type
      Participant withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Poor/non-compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Pregnancy
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        471
      2. group Id
        FG001
        num Subjects
        474
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        143
      comment
      Normal Completion
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        408
      2. group Id
        FG001
        num Subjects
        331
      type
      NOT COMPLETED
    title
    Treated With Study Drug
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        143
      comment
      Continuing in Long Term Follow Up
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        129
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Long Term Follow-Up
pre Assignment Details
Protocol definition of Enrolled population: All 1211 participants who signed the Informed Consent Form; 951 were randomized to treatment and 945 were treated. Reasons for not being randomized: 193 were ineligible; 42 refused; 19 could not be randomized within 12 weeks after complete lymph node dissection; 6 due to other reasons.
Complete source fields
groups
  1. description
    Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    FG000
    title
    Ipilimumab 10mg/kg
  2. description
    Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        475
      2. group Id
        FG001
        num Subjects
        476
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        471
      2. group Id
        FG001
        num Subjects
        474
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Randomized to Study Drug
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        282
      type
      Recurrence of disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        22
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        21
      type
      Participant withdrew consent
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Poor/non-compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Pregnancy
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reason
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        471
      2. group Id
        FG001
        num Subjects
        474
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        63
      2. group Id
        FG001
        num Subjects
        143
      comment
      Normal Completion
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        408
      2. group Id
        FG001
        num Subjects
        331
      type
      NOT COMPLETED
    title
    Treated With Study Drug
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        143
      comment
      Continuing in Long Term Follow Up
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        129
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Long Term Follow-Up
pre Assignment Details
Protocol definition of Enrolled population: All 1211 participants who signed the Informed Consent Form; 951 were randomized to treatment and 945 were treated. Reasons for not being randomized: 193 were ineligible; 42 refused; 19 could not be randomized within 12 weeks after complete lymph node dissection; 6 due to other reasons.

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Preserved source evidence · Not medical advice