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NCT03654833 · OUTCOME

Objective Response Rate (ORR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.

Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma · Source last updated 2026-08-17

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
24 weeks

What was measured

This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD

Groups in this outcome

MiST-1

Rucaparib in DNA damage sensitive relapsed mesothelioma

MiST-2

Abemaciclib in p16INK4A negative mesothelioma

MiST-3

Pembrolizumab and bemcentinib in relapsed mesothelioma

MiST-4

Atezolizumab and Bevacizumab in relapsed mesothelioma

MiST-5

Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma

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

Analysis denominator · Participants

GroupSource count
MiST-126
MiST-226
MiST-326
MiST-426
MiST-526

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MiST-13Not reportedNot reportedNot reportedNot reported
MiST-24Not reportedNot reportedNot reportedNot reported
MiST-34Not reportedNot reportedNot reportedNot reported
MiST-41Not reportedNot reportedNot reportedNot reported
MiST-54Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.2
    group Ids
    1. OG000
    non Inferiority Comment
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    11.5
  2. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
  3. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
  4. ci Lower Limit
    0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.6
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    3.8
  5. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG004
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
Complete source fields
analyses
  1. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    30.2
    group Ids
    1. OG000
    non Inferiority Comment
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    11.5
  2. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
  3. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
  4. ci Lower Limit
    0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.6
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    3.8
  5. ci Lower Limit
    4.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    34.9
    group Description
    The secondary analysis of the secondary outcome, ORR24w, will be analysed in the efficacy population. Patients will be included in the analysis if they have received at least one dose of study treatment. A total of 26 evaluable patients will be analysed for this arm. Proportion of patients with ORR will be presented with exact 95% confidence intervals.
    group Ids
    1. OG004
    non Inferiority Type
    OTHER
    param Type
    Proportion
    param Value
    15.4
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      26
    5. group Id
      OG004
      value
      26
    units
    Participants
description
This will be assessed using CT scan evidence according to modified RECIST 1.1 criteria reporting. Scans will be undertaken every 6 weeks. Analysis will be timed from study entry using the baseline CT scan results until completion of treatment cycles, confirmed disease progression or death - whichever comes first. Complete response (CR): disappearance of all target and non-target lesions with no evidence of tumour elsewhere Partial response (PR): reduction of at least 30% in the sum of all measurements with no evidence of significant disease progression in non-target lesions or new lesions Progressive disease (PD): 1: increase of at least 20% in the sum of all measurements compared with the previous best response, 2: appearance of one or more significant (overall 20% increase in tumour diameters) new lesions, 3: significant increase in target lesions Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD
groups
  1. description
    Rucaparib in DNA damage sensitive relapsed mesothelioma
    id
    OG000
    title
    MiST-1
  2. description
    Abemaciclib in p16INK4A negative mesothelioma
    id
    OG001
    title
    MiST-2
  3. description
    Pembrolizumab and bemcentinib in relapsed mesothelioma
    id
    OG002
    title
    MiST-3
  4. description
    Atezolizumab and Bevacizumab in relapsed mesothelioma
    id
    OG003
    title
    MiST-4
  5. description
    Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma
    id
    OG004
    title
    MiST-5
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
24 weeks
title
Objective Response Rate (ORR) at 24 Weeks Assessed by Modified RECIST 1.1, in Patients With Relapsed Mesothelioma.
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Independent clinical review pending · Not medical advice