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NCT02899299 · OUTCOME

Overall Survival (OS) According to PD-L1 Expression Level

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients · Source last updated 2024-05-21

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 date to the date of death (Up to 76 Months)

What was measured

PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis. OS was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.

Analysis population: All PD-L1 evaluable participants with baseline expression \<1% or ≥1%

Groups in this outcome

Treatment A

Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W

Treatment B

Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles

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

Analysis denominator · Participants

GroupSource count
Treatment A289
Treatment B297

Reported measurements

<1% PD-L1

Analysis denominator · Participants

GroupSource count
Treatment A57
Treatment B78
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A17.3Not reported10.123.9Not reported
Treatment B16.6Not reported13.420.8Not reported
≥1% PD-L1

Analysis denominator · Participants

GroupSource count
Treatment A232
Treatment B219
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A18.0Not reported16.821.5Not reported
Treatment B13.3Not reported11.615.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.32
    group Description
    \<1% PD-L1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A vs Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
  2. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    ≥1% PD-L1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A vs Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.32
    group Description
    \<1% PD-L1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A vs Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
  2. ci Lower Limit
    0.59
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    ≥1% PD-L1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A vs Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.72
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.1
        upper Limit
        23.9
        value
        17.3
      2. group Id
        OG001
        lower Limit
        13.4
        upper Limit
        20.8
        value
        16.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        78
      units
      Participants
    title
    <1% PD-L1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.8
        upper Limit
        21.5
        value
        18.0
      2. group Id
        OG001
        lower Limit
        11.6
        upper Limit
        15.4
        value
        13.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        219
      units
      Participants
    title
    ≥1% PD-L1
denoms
  1. counts
    1. group Id
      OG000
      value
      289
    2. group Id
      OG001
      value
      297
    units
    Participants
description
PD-L1 Expression is defined as the percent of tumor cells membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 immunohistochemistry (IHC) assay. This is referred to as quantifiable PD-L1 expression and efficacy is determined by overall survival (OS) analysis. OS was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
    id
    OG000
    title
    Treatment A
  2. description
    Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
    id
    OG001
    title
    Treatment B
param Type
MEDIAN
population Description
All PD-L1 evaluable participants with baseline expression \<1% or ≥1%
reporting Status
POSTED
time Frame
From randomization date to the date of death (Up to 76 Months)
title
Overall Survival (OS) According to PD-L1 Expression Level
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice