Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02784171 · OUTCOME

Phase II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
PFS 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

PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report).

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

Arm C - Pembrolizumab (Phase II Only)

Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years 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/Pemetrexed21
Arm B - Cisplatin/Pemetrexed/Pembrolizumab19
Arm C - Pembrolizumab (Phase II Only)40

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Cisplatin/Pemetrexed6.7Not reported2.78.4Not reported
Arm B - Cisplatin/Pemetrexed/Pembrolizumab6.8Not reported3.915Not reported
Arm C - Pembrolizumab (Phase II Only)5.26Not reported2.811.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        8.4
        value
        6.7
      2. group Id
        OG001
        lower Limit
        3.9
        upper Limit
        15
        value
        6.8
      3. group Id
        OG002
        lower Limit
        2.8
        upper Limit
        11.8
        value
        5.26
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      40
    units
    Participants
description
PFS was calculated for all randomized patients from the day of randomization until the first observation of disease progression (date of objective relapse or progression of Relapse/Progression Report) or death due to any cause (recorded in Date/Cause of Death Section of Death Report).
dispersion Type
95% Confidence Interval
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
  3. description
    Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years Pembrolizumab
    id
    OG002
    title
    Arm C - Pembrolizumab (Phase II Only)
param Type
MEDIAN
reporting Status
POSTED
time Frame
PFS 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 II: Progression Free Survival Measured as Time From Randomization to First Observation of Objective Disease Relapse or Progression
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice