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NCT02252042 · BASELINE

Baseline characteristics

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) · Source last updated 2023-07-17

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
      247
    2. group Id
      BG001
      value
      248
    3. group Id
      BG002
      value
      495
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
    id
    BG001
    title
    Standard Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          60.3
        2. group Id
          BG001
          spread
          8.6
          value
          60.2
        3. group Id
          BG002
          spread
          9.2
          value
          60.2
    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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          412
        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
          21
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          377
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          85
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
        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
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          413
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
        title
        Unknown or Not Reported
    description
    The race of participants is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          196
        title
        TPS = 0%
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          166
        title
        1% ≤ TPS <50%
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          129
        title
        TPS ≥ 50%
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥50% were classified as PD-L1 strongly positive and participants with a TPS \<50% were classified as not strongly positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          139
        title
        EGOG PS=0
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          355
        title
        ECOG PS=1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        ECOG PS=2
    description
    Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature; Grade 2: Ambulatory \& capable of all selfcare but unable to carry out any work activities, up \& about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          118
        title
        Positive HPV Status
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          377
        title
        Negative HPV Status
    description
    Participants were assessed for the presence or absence of HPV in their tumors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Papillomavirus (HPV) Tumor Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          104
        title
        PD-L1 CPS <1
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          387
        title
        PD-L1 CPS ≥1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a CPS ≥1 were classified as PD-L1 positive and participants with a CPS \<1 were classified as PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Combined Positive Score (CPS) Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      247
    2. group Id
      BG001
      value
      248
    3. group Id
      BG002
      value
      495
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received standard treatment of either methotrexate 40 mg/m\^2 IV (could be escalated to 60 mg/m\^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m\^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m\^2 IV loading dose on Day 1 and 250 mg/m\^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m\^2 on Days 1, 8, and 15 of each subsequent 3-week cycle.
    id
    BG001
    title
    Standard Treatment
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          60.3
        2. group Id
          BG001
          spread
          8.6
          value
          60.2
        3. group Id
          BG002
          spread
          9.2
          value
          60.2
    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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          83
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          412
        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
          21
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          377
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          85
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
        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
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          413
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          32
        title
        Unknown or Not Reported
    description
    The race of participants is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          196
        title
        TPS = 0%
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          166
        title
        1% ≤ TPS <50%
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          129
        title
        TPS ≥ 50%
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥50% were classified as PD-L1 strongly positive and participants with a TPS \<50% were classified as not strongly positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Expression Level: Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          139
        title
        EGOG PS=0
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          355
        title
        ECOG PS=1
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        ECOG PS=2
    description
    Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature; Grade 2: Ambulatory \& capable of all selfcare but unable to carry out any work activities, up \& about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          118
        title
        Positive HPV Status
      2. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          377
        title
        Negative HPV Status
    description
    Participants were assessed for the presence or absence of HPV in their tumors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Papillomavirus (HPV) Tumor Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          104
        title
        PD-L1 CPS <1
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          191
        3. group Id
          BG002
          value
          387
        title
        PD-L1 CPS ≥1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a CPS ≥1 were classified as PD-L1 positive and participants with a CPS \<1 were classified as PD-L1 negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Combined Positive Score (CPS) Status
    unit Of Measure
    Participants

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