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NCT01844505 · OUTCOME

Progression-Free 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 disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)

What was measured

PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 \>=5% or PD-L1 \<5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.

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
Nivolumab2.83Not reported2.765.39Not reported
Nivolumab + Ipilimumab11.17Not reported6.9326.68Not reported
Ipilimumab2.76Not reported2.662.86Not 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
Nivolumab16.20Not reported8.1127.66Not reported
Nivolumab + Ipilimumab16.72Not reported9.72NAUpper 95% Confidence Interval was not reached.
Ipilimumab3.48Not reported2.834.17Not 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
Nivolumab5.32Not reported2.966.87Not reported
Nivolumab + Ipilimumab11.17Not reported8.3122.18Not reported
Ipilimumab2.83Not reported2.763.02Not 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
Nivolumab22.34Not reported9.46NAUpper 95% Confidence Interval was not reached.
Nivolumab + Ipilimumab22.11Not reported9.72NAUpper 95% Confidence Interval was not reached.
Ipilimumab3.94Not reported2.794.21Not 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
Nivolumab5.62Not reported3.098.87Not reported
Nivolumab + Ipilimumab11.10Not reported8.0218.14Not reported
Ipilimumab2.83Not reported2.763.02Not 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
Nivolumab21.98Not reported9.07NAUpper 95% Confidence Interval was not reached.
Nivolumab + IpilimumabNANot reported13.96NAMedian and upper 95% Confidence Interval were not reached.
Ipilimumab4.11Not reported2.795.59Not 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
Nivolumab2.99Not reported2.666.93Not reported
Nivolumab + Ipilimumab6.93Not reported2.7920.04Not reported
Ipilimumab2.83Not reported2.606.41Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    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
    0.63
  2. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    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
    0.39
  3. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    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
    0.63
  4. ci Lower Limit
    0.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    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
    0.45
  5. ci Lower Limit
    0.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.53
    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
    0.40
  6. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.21
    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
    0.90
  7. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    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
    0.57
  8. ci Lower Limit
    0.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.53
    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
    0.42
  9. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    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
    0.73
  10. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.60
    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
    0.40
  11. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    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
    0.35
  12. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.38
    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
    0.87
Complete source fields
analyses
  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.85
    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
    0.63
  2. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    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
    0.39
  3. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.87
    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
    0.63
  4. ci Lower Limit
    0.34
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    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
    0.45
  5. ci Lower Limit
    0.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.53
    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
    0.40
  6. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.21
    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
    0.90
  7. ci Lower Limit
    0.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.71
    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
    0.57
  8. ci Lower Limit
    0.33
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.53
    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
    0.42
  9. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    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
    0.73
  10. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.60
    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
    0.40
  11. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.54
    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
    0.35
  12. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.38
    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
    0.87
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.76
        upper Limit
        5.39
        value
        2.83
      2. group Id
        OG001
        lower Limit
        6.93
        upper Limit
        26.68
        value
        11.17
      3. group Id
        OG002
        lower Limit
        2.66
        upper Limit
        2.86
        value
        2.76
    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. group Id
        OG000
        lower Limit
        8.11
        upper Limit
        27.66
        value
        16.20
      2. comment
        Upper 95% Confidence Interval was not reached.
        group Id
        OG001
        lower Limit
        9.72
        upper Limit
        NA
        value
        16.72
      3. group Id
        OG002
        lower Limit
        2.83
        upper Limit
        4.17
        value
        3.48
    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
        2.96
        upper Limit
        6.87
        value
        5.32
      2. group Id
        OG001
        lower Limit
        8.31
        upper Limit
        22.18
        value
        11.17
      3. group Id
        OG002
        lower Limit
        2.76
        upper Limit
        3.02
        value
        2.83
    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
        9.46
        upper Limit
        NA
        value
        22.34
      2. comment
        Upper 95% Confidence Interval was not reached.
        group Id
        OG001
        lower Limit
        9.72
        upper Limit
        NA
        value
        22.11
      3. group Id
        OG002
        lower Limit
        2.79
        upper Limit
        4.21
        value
        3.94
    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
        3.09
        upper Limit
        8.87
        value
        5.62
      2. group Id
        OG001
        lower Limit
        8.02
        upper Limit
        18.14
        value
        11.10
      3. group Id
        OG002
        lower Limit
        2.76
        upper Limit
        3.02
        value
        2.83
    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
        9.07
        upper Limit
        NA
        value
        21.98
      2. comment
        Median and upper 95% Confidence Interval were not reached.
        group Id
        OG001
        lower Limit
        13.96
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        2.79
        upper Limit
        5.59
        value
        4.11
    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. group Id
        OG000
        lower Limit
        2.66
        upper Limit
        6.93
        value
        2.99
      2. group Id
        OG001
        lower Limit
        2.79
        upper Limit
        20.04
        value
        6.93
      3. group Id
        OG002
        lower Limit
        2.60
        upper Limit
        6.41
        value
        2.83
    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
PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 \>=5% or PD-L1 \<5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.
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 disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)
title
Progression-Free Survival Based on PD-L1 Expression Level
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice