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NCT02899299 · OUTCOME

Progression Free Survival (PFS)

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 first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)

What was measured

Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. Progressive disease (PD)=At least a 20% increase in the sum of the Total Tumor Measurement.

Analysis population: All Randomized Participants

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 A303
Treatment B302

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A6.77Not reported5.597.36Not reported
Treatment B7.23Not reported6.938.05Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    estimate Comment
    Stratified Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
Complete source fields
analyses
  1. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    estimate Comment
    Stratified Cox proportional hazard model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment B
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.59
        upper Limit
        7.36
        value
        6.77
      2. group Id
        OG001
        lower Limit
        6.93
        upper Limit
        8.05
        value
        7.23
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      302
    units
    Participants
description
Progression Free Survival is defined as the time between the date of randomization and the date of first documented tumor progression per Blinded Independent Central Review (BICR) assessments (using adapted m-RECIST and RECIST 1.1), or death due to any cause, whichever occurs first. Participants who received subsequent anticancer therapy prior to documented progression were censored at the date of the last evaluable tumor assessment conducted on or prior to the date of initiation of the subsequent anticancer therapy. 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
MEDIAN
population Description
All Randomized Participants
reporting Status
POSTED
time Frame
From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice