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NCT02784171 · OUTCOME

Phase III: Objective Response Rate

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma · Source last updated 2024-12-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Response was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.

What was measured

Objective response rate was defined as the proportion of patients with best objective response being complete response (CR) or partial response (PR).

Groups in this outcome

Arm A - Cisplatin/Pemetrexed

Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed

Arm B - Cisplatin/Pemetrexed/Pembrolizumab

Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab

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

Analysis denominator · Participants

GroupSource count
Arm A - Cisplatin/Pemetrexed218
Arm B - Cisplatin/Pemetrexed/Pembrolizumab222

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cisplatin/Pemetrexed83Not reportedNot reportedNot reportedNot reported
Arm B - Cisplatin/Pemetrexed/Pembrolizumab138Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        138
denoms
  1. counts
    1. group Id
      OG000
      value
      218
    2. group Id
      OG001
      value
      222
    units
    Participants
description
Objective response rate was defined as the proportion of patients with best objective response being complete response (CR) or partial response (PR).
groups
  1. description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    OG000
    title
    Arm A - Cisplatin/Pemetrexed
  2. description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
    id
    OG001
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Response was monitored continuously, with assessments every 6 weeks for 3 visits, then every 12 weeks, 4 weeks post-discontinuation, every 12 weeks until progression, and every 24 weeks until death, over an average of 16.2 months.
title
Phase III: Objective Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice