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NCT01274338 · OUTCOME

5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])

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.

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months for 2 years, then every 6 months for years 3-5

What was measured

Overall survival is defined as the time from randomization to death or date last known alive.

Analysis population: Concurrently randomized patients on Arms B and C

Groups in this outcome

Arm B (HDI)

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.

Arm C (LIP)

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm B (HDI)528
Arm C (LIP)523

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm B (HDI)0.67Not reported0.620.72Not reported
Arm C (LIP)0.72Not reported0.680.76Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.044
    statistical Comment
    Stratified logrank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.044
    statistical Comment
    Stratified logrank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.62
        upper Limit
        0.72
        value
        0.67
      2. group Id
        OG001
        lower Limit
        0.68
        upper Limit
        0.76
        value
        0.72
denoms
  1. counts
    1. group Id
      OG000
      value
      528
    2. group Id
      OG001
      value
      523
    units
    Participants
description
Overall survival is defined as the time from randomization to death or date last known alive.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Arm B (HDI)
  2. 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
    OG001
    title
    Arm C (LIP)
param Type
NUMBER
population Description
Concurrently randomized patients on Arms B and C
reporting Status
POSTED
time Frame
Assessed every 3 months for 2 years, then every 6 months for years 3-5
title
5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice