Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02358031 · BASELINE

Baseline characteristics

A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) · Source last updated 2025-07-18

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
      301
    2. group Id
      BG001
      value
      281
    3. group Id
      BG002
      value
      300
    4. group Id
      BG003
      value
      882
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    BG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    BG001
    title
    Pembrolizumab + Chemotherapy (Pembro Combo)
  3. description
    Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    BG002
    title
    Cetuximab + Chemotherapy (Control)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          61.2
        2. group Id
          BG001
          spread
          9.8
          value
          60.7
        3. group Id
          BG002
          spread
          10.0
          value
          61.0
        4. group Id
          BG003
          spread
          9.7
          value
          61.0
    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
          51
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          147
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          735
        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
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          135
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          231
        4. group Id
          BG003
          value
          677
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          70
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          172
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          224
        4. group Id
          BG003
          value
          646
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          25
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          345
        title
        ECOG = 0
      2. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          183
        4. group Id
          BG003
          value
          537
        title
        ECOG = 1
    description
    An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the trial.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          190
        title
        HPV Positive
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          233
        4. group Id
          BG003
          value
          692
        title
        HPV Negative
    description
    HPV status for oropharynx cancer as determined by p16 immunohistochemistry (IHC) (positive vs. negative); HPV status for participants without oropharynx cancer was considered HPV negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Papillomavirus (HPV) Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          199
        title
        Strongly Positive
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          683
        title
        Not Strongly Positive
    description
    The Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) Status indicates the degree by which participants tumors stain positive for PD-L1 by IHC staining (i.e. strongly positive or not strongly positive). 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
    PD-L1 TPS Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          128
        title
        CPS<1
      2. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          255
        4. group Id
          BG003
          value
          754
        title
        CPS ≥1
    description
    The PD-L1 Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\<1 and CPS≥1 at baseline is presented. Participants with a CPS\<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS ≥1 Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          175
        4. group Id
          BG003
          value
          496
        title
        CPS <20
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          381
        title
        CPS ≥20
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        Missing
    description
    The PD-L1 CPS Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\<20 and CPS ≥20 at baseline is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS ≥20 Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      301
    2. group Id
      BG001
      value
      281
    3. group Id
      BG002
      value
      300
    4. group Id
      BG003
      value
      882
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    BG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    BG001
    title
    Pembrolizumab + Chemotherapy (Pembro Combo)
  3. description
    Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    BG002
    title
    Cetuximab + Chemotherapy (Control)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          61.2
        2. group Id
          BG001
          spread
          9.8
          value
          60.7
        3. group Id
          BG002
          spread
          10.0
          value
          61.0
        4. group Id
          BG003
          spread
          9.7
          value
          61.0
    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
          51
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          147
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          735
        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
          46
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          135
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          231
        4. group Id
          BG003
          value
          677
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          70
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          14
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          172
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          21
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          224
        4. group Id
          BG003
          value
          646
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          25
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          345
        title
        ECOG = 0
      2. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          183
        4. group Id
          BG003
          value
          537
        title
        ECOG = 1
    description
    An ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the trial.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          67
        4. group Id
          BG003
          value
          190
        title
        HPV Positive
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          221
        3. group Id
          BG002
          value
          233
        4. group Id
          BG003
          value
          692
        title
        HPV Negative
    description
    HPV status for oropharynx cancer as determined by p16 immunohistochemistry (IHC) (positive vs. negative); HPV status for participants without oropharynx cancer was considered HPV negative.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Papillomavirus (HPV) Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          66
        4. group Id
          BG003
          value
          199
        title
        Strongly Positive
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          683
        title
        Not Strongly Positive
    description
    The Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) Status indicates the degree by which participants tumors stain positive for PD-L1 by IHC staining (i.e. strongly positive or not strongly positive). 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
    PD-L1 TPS Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          128
        title
        CPS<1
      2. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          255
        4. group Id
          BG003
          value
          754
        title
        CPS ≥1
    description
    The PD-L1 Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\<1 and CPS≥1 at baseline is presented. Participants with a CPS\<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS ≥1 Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          175
        4. group Id
          BG003
          value
          496
        title
        CPS <20
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          381
        title
        CPS ≥20
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        Missing
    description
    The PD-L1 CPS Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by IHC. The number of participants with CPS\<20 and CPS ≥20 at baseline is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS ≥20 Status
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice