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NCT03761914 · BASELINE

Baseline characteristics

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers · Source last updated 2024-11-19

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
      25
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      26
    units
    Participants
groups
  1. description
    * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
    id
    BG000
    title
    Ovarian Cancer (OvC)
  2. description
    Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
    id
    BG001
    title
    Colorectal (CRC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.9
          value
          63.8
        2. group Id
          BG001
          spread
          0
          value
          40
        3. group Id
          BG002
          spread
          7.9
          value
          63.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          76
          value
          65
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          40
          value
          40
        3. group Id
          BG002
          lower Limit
          50
          upper Limit
          76
          value
          65
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          94
          value
          61.7
        2. group Id
          BG001
          lower Limit
          69.5
          upper Limit
          69.5
          value
          69.5
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          94
          value
          61.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          150
          upper Limit
          172
          value
          160
        2. group Id
          BG001
          lower Limit
          169
          upper Limit
          169
          value
          169
        3. group Id
          BG002
          lower Limit
          150
          upper Limit
          172
          value
          160
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.6
          upper Limit
          34.2
          value
          25.03
        2. group Id
          BG001
          lower Limit
          24.3
          upper Limit
          24.3
          value
          24.3
        3. group Id
          BG002
          lower Limit
          18.6
          upper Limit
          34.2
          value
          25.03
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    BMI
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          18
        title
        1
    description
    ECOG measures patient's functional status. Grade 0 is best, grade 5 worst. Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities Grade 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair Grade 5: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Baseline ECOG
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          13
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        5
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        title
        Unknown / Not reported
    description
    The number of anti-cancer therapies that patient received before joining the study.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Lines of prior therapy
    unit Of Measure
    Participants
population Description
Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      26
    units
    Participants
groups
  1. description
    * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
    id
    BG000
    title
    Ovarian Cancer (OvC)
  2. description
    Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
    id
    BG001
    title
    Colorectal (CRC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.9
          value
          63.8
        2. group Id
          BG001
          spread
          0
          value
          40
        3. group Id
          BG002
          spread
          7.9
          value
          63.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          76
          value
          65
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          40
          value
          40
        3. group Id
          BG002
          lower Limit
          50
          upper Limit
          76
          value
          65
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          26
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          94
          value
          61.7
        2. group Id
          BG001
          lower Limit
          69.5
          upper Limit
          69.5
          value
          69.5
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          94
          value
          61.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          150
          upper Limit
          172
          value
          160
        2. group Id
          BG001
          lower Limit
          169
          upper Limit
          169
          value
          169
        3. group Id
          BG002
          lower Limit
          150
          upper Limit
          172
          value
          160
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Height
    unit Of Measure
    cm
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.6
          upper Limit
          34.2
          value
          25.03
        2. group Id
          BG001
          lower Limit
          24.3
          upper Limit
          24.3
          value
          24.3
        3. group Id
          BG002
          lower Limit
          18.6
          upper Limit
          34.2
          value
          25.03
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    BMI
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          18
        title
        1
    description
    ECOG measures patient's functional status. Grade 0 is best, grade 5 worst. Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities Grade 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours Grade 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair Grade 5: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Baseline ECOG
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          13
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        4
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        5
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        title
        Unknown / Not reported
    description
    The number of anti-cancer therapies that patient received before joining the study.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.
    title
    Lines of prior therapy
    unit Of Measure
    Participants
population Description
Only the Ovarian Cancer (OvC) arm enrolled fully. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety. The other cohorts did not open.

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