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NCT02899299 · OUTCOME

Disease Control Rate (DCR)

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

Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). 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; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A76.6Not reported71.481.2Not reported
Treatment B85.8Not reported81.389.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.4
        upper Limit
        81.2
        value
        76.6
      2. group Id
        OG001
        lower Limit
        81.3
        upper Limit
        89.5
        value
        85.8
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      302
    units
    Participants
description
Disease Control Rate is defined as the percentage of all randomized participants whose Best Overall Response was complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-PD as assessed by Blinded Independent Central Review (BICR). 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; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Non-CR/Non-PD: Persistence of one or more non-target lesion(s).
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 Randomized Participants
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
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice