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NCT05005429 · BASELINE

Baseline characteristics

Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma · Source last updated 2025-12-23

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

denoms
  1. counts
    1. group Id
      BG000
      value
      46
    units
    Participants
groups
  1. description
    Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals . Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
    id
    BG000
    title
    Experimental: Bintrafusp Alfa (M7824)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          84
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Latin
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Never smoker (<= 100 cigarettes/lifetime)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Former smoker (>= 1 year)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Active smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking habit
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      Second (received at least 1 previous line)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Third (received two previous lines)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lines of therapy
    unit Of Measure
    Participants
population Description
47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      46
    units
    Participants
groups
  1. description
    Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals . Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
    id
    BG000
    title
    Experimental: Bintrafusp Alfa (M7824)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          36
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          84
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Latin
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Never smoker (<= 100 cigarettes/lifetime)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Former smoker (>= 1 year)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Active smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking habit
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      Second (received at least 1 previous line)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Third (received two previous lines)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lines of therapy
    unit Of Measure
    Participants
population Description
47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice