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NCT00636168 · OUTCOME

Overall Survival in the Intent to Treat (ITT) Population

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From June 2008 to January 2016 (approximately 90 months)

What was measured

OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.

Analysis population: Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization

Groups in this outcome

Ipilimumab 10mg/kg

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).

Placebo

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).

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

Analysis denominator · Participants

GroupSource count
Ipilimumab 10mg/kg475
Placebo476

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab 10mg/kg86.60Not reported86.60NAUpper limit was not reached because the number of participants with a followup of more than 7 years was too small
PlaceboNANot reported59.30NAMedian and upper limit were not reached because the number of participants with a followup of more than 7 years was too small

Source statistical analyses

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

  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    0.88
    group Description
    Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0013
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
    statistical Comment
    stratified 2-sided log-rank test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    0.88
    group Description
    Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0013
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
    statistical Comment
    stratified 2-sided log-rank test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Upper limit was not reached because the number of participants with a followup of more than 7 years was too small
        group Id
        OG000
        lower Limit
        86.60
        upper Limit
        NA
        value
        86.60
      2. comment
        Median and upper limit were not reached because the number of participants with a followup of more than 7 years was too small
        group Id
        OG001
        lower Limit
        59.30
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      475
    2. group Id
      OG001
      value
      476
    units
    Participants
description
OS was defined as the time from the date of randomization to the date of death. For those participants who had not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intent-to-treat population: All randomized participants, analyzed in the arm to which they were allocated by randomization
reporting Status
POSTED
time Frame
From June 2008 to January 2016 (approximately 90 months)
title
Overall Survival in the Intent to Treat (ITT) Population
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice