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NCT01844505 · OUTCOME

Rate of Overall Survival

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) · Source last updated 2025-05-21

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

Measure
NUMBER
Unit
Probability of survival at Time T
Interval / dispersion
95% Confidence Interval
Time frame
24 months

What was measured

OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity

Nivolumab + Ipilimumab

Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity

Ipilimumab

Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses

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

Analysis denominator · Participants

GroupSource count
Nivolumab316
Nivolumab + Ipilimumab314
Ipilimumab315

Reported measurements

Rate of OS at 6 months
Values in Probability of survival at Time T · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab0.85Not reported0.810.89Not reported
Nivolumab + Ipilimumab0.86Not reported0.810.89Not reported
Ipilimumab0.82Not reported0.780.86Not reported
Rate of OS at 12 months
Values in Probability of survival at Time T · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab0.74Not reported0.690.79Not reported
Nivolumab + Ipilimumab0.73Not reported0.680.78Not reported
Ipilimumab0.67Not reported0.610.72Not reported
Rate of OS at 24 months
Values in Probability of survival at Time T · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab0.59Not reported0.530.64Not reported
Nivolumab + Ipilimumab0.64Not reported0.590.69Not reported
Ipilimumab0.45Not reported0.390.50Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.81
        upper Limit
        0.89
        value
        0.85
      2. group Id
        OG001
        lower Limit
        0.81
        upper Limit
        0.89
        value
        0.86
      3. group Id
        OG002
        lower Limit
        0.78
        upper Limit
        0.86
        value
        0.82
    title
    Rate of OS at 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.69
        upper Limit
        0.79
        value
        0.74
      2. group Id
        OG001
        lower Limit
        0.68
        upper Limit
        0.78
        value
        0.73
      3. group Id
        OG002
        lower Limit
        0.61
        upper Limit
        0.72
        value
        0.67
    title
    Rate of OS at 12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        0.64
        value
        0.59
      2. group Id
        OG001
        lower Limit
        0.59
        upper Limit
        0.69
        value
        0.64
      3. group Id
        OG002
        lower Limit
        0.39
        upper Limit
        0.50
        value
        0.45
    title
    Rate of OS at 24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      316
    2. group Id
      OG001
      value
      314
    3. group Id
      OG002
      value
      315
    units
    Participants
description
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
    id
    OG000
    title
    Nivolumab
  2. description
    Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
    id
    OG001
    title
    Nivolumab + Ipilimumab
  3. description
    Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
    id
    OG002
    title
    Ipilimumab
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
24 months
title
Rate of Overall Survival
type
PRIMARY
unit Of Measure
Probability of survival at Time T

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

Preserved source evidence · Not medical advice