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NCT02899299 · OUTCOME

Objective Response Rate (ORR) 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (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 objective response rate (ORR) analysis. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A21.1Not reported11.433.9Not reported
Treatment B41.0Not reported30.052.7Not reported
≥1% PD-L1

Analysis denominator · Participants

GroupSource count
Treatment A232
Treatment B219
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A43.1Not reported36.649.7Not reported
Treatment B45.7Not reported38.952.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.4
        upper Limit
        33.9
        value
        21.1
      2. group Id
        OG001
        lower Limit
        30.0
        upper Limit
        52.7
        value
        41.0
    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
        36.6
        upper Limit
        49.7
        value
        43.1
      2. group Id
        OG001
        lower Limit
        38.9
        upper Limit
        52.5
        value
        45.7
    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 objective response rate (ORR) analysis. ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) or partial response (PR) per Blinded Independent Central Review (BICR) assessments. Per adapted m-RECIST for pleural mesothelioma, each single tumor measurement must be at least 10 mm in length to qualify as measureable disease and contribute to the sum that defines the pleural uni-variate measure. per RECIST 1.1 for solid tumors, confirmation of response required: CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the Total Tumor Measurement; Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.
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
NUMBER
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 objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
title
Objective Response Rate (ORR) According to PD-L1 Expression Level
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice