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NCT03126630 · OUTCOME

Phase 2 Confirmed Tumor Response Rate (Phase II)

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma · Source last updated 2026-04-01

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
Up to 2 years

What was measured

Will be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

Group I (Pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies

Group II (Anetumab Ravtansine, Pembrolizumab)

Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Group I (Pembrolizumab)17
Group II (Anetumab Ravtansine, Pembrolizumab)18

Reported measurements

NE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I (Pembrolizumab)2Not reportedNot reportedNot reportedNot reported
Group II (Anetumab Ravtansine, Pembrolizumab)4Not reportedNot reportedNot reportedNot reported
PD (Preliminary)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I (Pembrolizumab)6Not reportedNot reportedNot reportedNot reported
Group II (Anetumab Ravtansine, Pembrolizumab)2Not reportedNot reportedNot reportedNot reported
PD (Confirmed)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I (Pembrolizumab)3Not reportedNot reportedNot reportedNot reported
Group II (Anetumab Ravtansine, Pembrolizumab)1Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I (Pembrolizumab)5Not reportedNot reportedNot reportedNot reported
Group II (Anetumab Ravtansine, Pembrolizumab)9Not reportedNot reportedNot reportedNot reported
PR (Confirmed)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I (Pembrolizumab)1Not reportedNot reportedNot reportedNot reported
Group II (Anetumab Ravtansine, Pembrolizumab)2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.27541
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.
    non Inferiority Type
    EQUIVALENCE
    p Value
    0.27541
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    NE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    PD (Preliminary)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    PD (Confirmed)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        9
    title
    SD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    PR (Confirmed)
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Will be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Upon radiologic documentation of disease progression, patients may cross over to Group II.\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
    id
    OG000
    title
    Group I (Pembrolizumab)
  2. description
    Patients receive anetumab ravtansine IV over 1 hour and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 12 months for anetumab ravtansine and up to 24 months for pembrolizumab in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Anetumab Ravtansine: Given IV\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pembrolizumab: Given IV\> \>\> \> \>\> Pharmacological Study: Correlative studies
    id
    OG001
    title
    Group II (Anetumab Ravtansine, Pembrolizumab)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 2 years
title
Phase 2 Confirmed Tumor Response Rate (Phase II)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice