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Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery · Source last updated 2026-09-08

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

groups
  1. description
    Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm A (HIP)
  2. description
    Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Arm B (HDI)
  3. description
    Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Arm C (LIP)
  4. description
    Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG003
    title
    Arm D (HIP; Pediatric)
  5. description
    Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG004
    title
    Arm E (HDI; Pediatric)
  6. description
    Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG005
    title
    Arm F (LIP; Pediatric)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        108
      3. group Id
        FG002
        num Subjects
        116
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        105
      3. group Id
        FG002
        num Subjects
        180
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      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
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Did not start treatment
    6. 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
      type
      Alternative therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      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
      type
      Other complicating diseases
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      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
      type
      Treatment arm was suspended due to toxicity
    9. 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
      type
      Pregnancy
    10. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Reason not reported
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        511
      2. group Id
        FG001
        num Subjects
        636
      3. group Id
        FG002
        num Subjects
        523
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        503
      2. group Id
        FG001
        num Subjects
        520
      3. group Id
        FG002
        num Subjects
        516
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Data Available for the FACT-G and FACT-BRM Analyses
    4. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Data Available for FACIT-D Analysis
    5. achievements
      1. group Id
        FG000
        num Subjects
        108
      2. group Id
        FG001
        num Subjects
        182
      3. group Id
        FG002
        num Subjects
        198
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        403
      2. group Id
        FG001
        num Subjects
        454
      3. group Id
        FG002
        num Subjects
        325
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
A total of 1673 patients, including 1670 adult patients and 3 pediatric patients, were accrued between June 17, 2011 and July 26, 2016. Accrual of adult patients were completed on August 15, 2014. The study was reactivated to accrue pediatric patients on September 23, 2014.
Complete source fields
groups
  1. description
    Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm A (HIP)
  2. description
    Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Arm B (HDI)
  3. description
    Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG002
    title
    Arm C (LIP)
  4. description
    Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG003
    title
    Arm D (HIP; Pediatric)
  5. description
    Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG004
    title
    Arm E (HDI; Pediatric)
  6. description
    Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. (ages 12-17)
    id
    FG005
    title
    Arm F (LIP; Pediatric)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        108
      3. group Id
        FG002
        num Subjects
        116
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        105
      3. group Id
        FG002
        num Subjects
        180
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      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
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        99
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        116
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Did not start treatment
    6. 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
      type
      Alternative therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      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
      type
      Other complicating diseases
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      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
      type
      Treatment arm was suspended due to toxicity
    9. 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
      type
      Pregnancy
    10. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      Reason not reported
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        511
      2. group Id
        FG001
        num Subjects
        636
      3. group Id
        FG002
        num Subjects
        523
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        503
      2. group Id
        FG001
        num Subjects
        520
      3. group Id
        FG002
        num Subjects
        516
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        110
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Data Available for the FACT-G and FACT-BRM Analyses
    4. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        114
      3. group Id
        FG002
        num Subjects
        97
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Data Available for FACIT-D Analysis
    5. achievements
      1. group Id
        FG000
        num Subjects
        108
      2. group Id
        FG001
        num Subjects
        182
      3. group Id
        FG002
        num Subjects
        198
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        403
      2. group Id
        FG001
        num Subjects
        454
      3. group Id
        FG002
        num Subjects
        325
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
A total of 1673 patients, including 1670 adult patients and 3 pediatric patients, were accrued between June 17, 2011 and July 26, 2016. Accrual of adult patients were completed on August 15, 2014. The study was reactivated to accrue pediatric patients on September 23, 2014.

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