Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01844505 · OUTCOME

Overall Survival Based on PD-L1 Expression Level

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until death (assessed up to approximately 128 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.

Analysis population: All randomized participants with evaluable PD-L1 expression level at baseline

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

PD-L1 < 1% (n=117, 123, 113)

Analysis denominator · Participants

GroupSource count
Nivolumab117
Nivolumab + Ipilimumab123
Ipilimumab113
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab23.46Not reported13.01NAUpper 95% Confidence Interval was not reached
Nivolumab + IpilimumabNANot reported26.45NAUpper 95% Confidence Interval was not reached
Ipilimumab18.56Not reported13.6723.20Not reported
PD-L1 >= 1% (n= 171, 155, 164)

Analysis denominator · Participants

GroupSource count
Nivolumab171
Nivolumab + Ipilimumab155
Ipilimumab164
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab85.09Not reported39.00NAUpper 95% Confidence Interval was not reached
Nivolumab + Ipilimumab82.30Not reported39.06NAUpper 95% Confidence Interval was not reached
Ipilimumab21.49Not reported16.8529.08Not reported
PD-L1 < 5% (n= 208, 210, 202)

Analysis denominator · Participants

GroupSource count
Nivolumab208
Nivolumab + Ipilimumab210
Ipilimumab202
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab35.94Not reported23.0659.24Not reported
Nivolumab + Ipilimumab65.94Not reported32.72114.37Not reported
Ipilimumab18.40Not reported13.7022.51Not reported
PD-L1 >= 5% (n= 80, 68, 75)

Analysis denominator · Participants

GroupSource count
Nivolumab80
Nivolumab + Ipilimumab68
Ipilimumab75
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab64.51Not reported33.64NAUpper 95% Confidence Interval was not reached
Nivolumab + Ipilimumab104.97Not reported39.06NAUpper 95% Confidence Interval was not reached
Ipilimumab28.88Not reported18.1044.16Not reported
PD-L1 < 10% (n= 229, 232, 223)

Analysis denominator · Participants

GroupSource count
Nivolumab229
Nivolumab + Ipilimumab232
Ipilimumab223
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab36.93Not reported23.4680.85Not reported
Nivolumab + Ipilimumab70.74Not reported34.83107.89Not reported
Ipilimumab18.56Not reported14.9823.03Not reported
PD-L1 >= 10% (n= 59, 46, 54)

Analysis denominator · Participants

GroupSource count
Nivolumab59
Nivolumab + Ipilimumab46
Ipilimumab54
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab43.63Not reported31.24NAUpper 95% Confidence Interval was not reached
Nivolumab + IpilimumabNANot reported39.06NAUpper 95% Confidence Interval was not reached
Ipilimumab29.08Not reported17.4546.55Not reported
PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38)

Analysis denominator · Participants

GroupSource count
Nivolumab28
Nivolumab + Ipilimumab36
Ipilimumab38
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab23.89Not reported11.76NAUpper 95% Confidence Interval was not reached
Nivolumab + IpilimumabNANot reported21.39NAMedian and Upper 95% Confidence Interval were not reached
Ipilimumab18.73Not reported8.4130.00Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
  3. ci Lower Limit
    0.55
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
  4. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
  5. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.67
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
  6. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.31
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
  7. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
  8. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
  9. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
  10. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
  11. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
  12. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.53
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
  3. ci Lower Limit
    0.55
    ci Pct Value
    95
    ci Upper Limit
    1.04
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.76
  4. ci Lower Limit
    0.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
  5. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.67
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
  6. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.31
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
  7. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.62
  8. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.66
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.52
  9. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.84
  10. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    estimate Comment
    HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
  11. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.59
  12. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.53
    estimate Comment
    HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
classes
  1. categories
    1. measurements
      1. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG000
        lower Limit
        13.01
        upper Limit
        NA
        value
        23.46
      2. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG001
        lower Limit
        26.45
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        13.67
        upper Limit
        23.20
        value
        18.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        123
      3. group Id
        OG002
        value
        113
      units
      Participants
    title
    PD-L1 < 1% (n=117, 123, 113)
  2. categories
    1. measurements
      1. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG000
        lower Limit
        39.00
        upper Limit
        NA
        value
        85.09
      2. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG001
        lower Limit
        39.06
        upper Limit
        NA
        value
        82.30
      3. group Id
        OG002
        lower Limit
        16.85
        upper Limit
        29.08
        value
        21.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        171
      2. group Id
        OG001
        value
        155
      3. group Id
        OG002
        value
        164
      units
      Participants
    title
    PD-L1 >= 1% (n= 171, 155, 164)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.06
        upper Limit
        59.24
        value
        35.94
      2. group Id
        OG001
        lower Limit
        32.72
        upper Limit
        114.37
        value
        65.94
      3. group Id
        OG002
        lower Limit
        13.70
        upper Limit
        22.51
        value
        18.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        208
      2. group Id
        OG001
        value
        210
      3. group Id
        OG002
        value
        202
      units
      Participants
    title
    PD-L1 < 5% (n= 208, 210, 202)
  4. categories
    1. measurements
      1. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG000
        lower Limit
        33.64
        upper Limit
        NA
        value
        64.51
      2. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG001
        lower Limit
        39.06
        upper Limit
        NA
        value
        104.97
      3. group Id
        OG002
        lower Limit
        18.10
        upper Limit
        44.16
        value
        28.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        68
      3. group Id
        OG002
        value
        75
      units
      Participants
    title
    PD-L1 >= 5% (n= 80, 68, 75)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.46
        upper Limit
        80.85
        value
        36.93
      2. group Id
        OG001
        lower Limit
        34.83
        upper Limit
        107.89
        value
        70.74
      3. group Id
        OG002
        lower Limit
        14.98
        upper Limit
        23.03
        value
        18.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        229
      2. group Id
        OG001
        value
        232
      3. group Id
        OG002
        value
        223
      units
      Participants
    title
    PD-L1 < 10% (n= 229, 232, 223)
  6. categories
    1. measurements
      1. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG000
        lower Limit
        31.24
        upper Limit
        NA
        value
        43.63
      2. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG001
        lower Limit
        39.06
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        17.45
        upper Limit
        46.55
        value
        29.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        46
      3. group Id
        OG002
        value
        54
      units
      Participants
    title
    PD-L1 >= 10% (n= 59, 46, 54)
  7. categories
    1. measurements
      1. comment
        Upper 95% Confidence Interval was not reached
        group Id
        OG000
        lower Limit
        11.76
        upper Limit
        NA
        value
        23.89
      2. comment
        Median and Upper 95% Confidence Interval were not reached
        group Id
        OG001
        lower Limit
        21.39
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        8.41
        upper Limit
        30.00
        value
        18.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        36
      3. group Id
        OG002
        value
        38
      units
      Participants
    title
    PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38)
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.
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
MEDIAN
population Description
All randomized participants with evaluable PD-L1 expression level at baseline
reporting Status
POSTED
time Frame
From randomization until death (assessed up to approximately 128 months)
title
Overall Survival Based on PD-L1 Expression Level
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice