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NCT01704287 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002) · Source last updated 2020-05-18

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
      180
    2. group Id
      BG001
      value
      181
    3. group Id
      BG002
      value
      179
    4. group Id
      BG003
      value
      540
    units
    Participants
groups
  1. description
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG000
    title
    Pembrolizumab 2 mg/kg
  2. description
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG001
    title
    Pembrolizumab 10 mg/kg
  3. description
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG002
    title
    Investigator-Choice Chemotherapy (ICC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.9
          value
          59.5
        2. group Id
          BG001
          spread
          13.3
          value
          60.1
        3. group Id
          BG002
          spread
          12.7
          value
          60.5
        4. group Id
          BG003
          spread
          13.6
          value
          60.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          114
        4. group Id
          BG003
          value
          327
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          294
        title
        PD-L1 Positive
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          134
        title
        PD-L1 Negative
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          112
        title
        Unknown
    description
    Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by immunohistochemistry assay and scored on a unique melanoma (Allred Proportion Score \[APS\]/Melanoma \[MEL\]) scale of 0 to 5 points. Participants with an APS score of ≥2 (membranous staining in ≥1% of cells) were considered to be PD-L1 Positive and participants with an APS score of 0 or 1 were considered to be PD-L1 Negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all randomized participants. Participants were included in the group to which they were initially randomized for Baseline Characteristics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      180
    2. group Id
      BG001
      value
      181
    3. group Id
      BG002
      value
      179
    4. group Id
      BG003
      value
      540
    units
    Participants
groups
  1. description
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG000
    title
    Pembrolizumab 2 mg/kg
  2. description
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG001
    title
    Pembrolizumab 10 mg/kg
  3. description
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    BG002
    title
    Investigator-Choice Chemotherapy (ICC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.9
          value
          59.5
        2. group Id
          BG001
          spread
          13.3
          value
          60.1
        3. group Id
          BG002
          spread
          12.7
          value
          60.5
        4. group Id
          BG003
          spread
          13.6
          value
          60.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          114
        4. group Id
          BG003
          value
          327
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          294
        title
        PD-L1 Positive
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          134
        title
        PD-L1 Negative
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          112
        title
        Unknown
    description
    Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by immunohistochemistry assay and scored on a unique melanoma (Allred Proportion Score \[APS\]/Melanoma \[MEL\]) scale of 0 to 5 points. Participants with an APS score of ≥2 (membranous staining in ≥1% of cells) were considered to be PD-L1 Positive and participants with an APS score of 0 or 1 were considered to be PD-L1 Negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status
    unit Of Measure
    Participants
population Description
The baseline analysis population consisted of all randomized participants. Participants were included in the group to which they were initially randomized for Baseline Characteristics.

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

Preserved source evidence · Not medical advice