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NCT03765918 · BASELINE

Baseline characteristics

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) · Source last updated 2026-07-31

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
      363
    2. group Id
      BG001
      value
      351
    3. group Id
      BG002
      value
      714
    units
    Participants
groups
  1. description
    Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    BG000
    title
    Pembrolizumab + Standard of Care (SOC)
  2. description
    Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    BG001
    title
    Standard of Care (SOC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.0
          value
          59.4
        2. group Id
          BG001
          spread
          10.0
          value
          60.6
        3. group Id
          BG002
          spread
          10.0
          value
          59.9
    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
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          151
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          286
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          563
        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
          55
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          101
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          598
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          95
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          284
        2. group Id
          BG001
          value
          270
        3. group Id
          BG002
          value
          554
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          29
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        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
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Oropharynx
      2. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          432
        title
        Oral Cavity
      3. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          154
        title
        Larynx
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          54
        title
        Hypopharynx
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    The primary tumor site was categorized as tumor in oropharynx, oral cavity, larynx, and hypopharynx. The number of participants with tumor at each site at baseline was presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Site
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          183
        title
        III
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          528
        title
        IVA
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        IVB
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    American Joint Committee on Cancer 8th edition TNM stratified (PT=primary tumor \[size \& invasion of nearby tissue\], LN=cancerous lymph nodes, Met=distant metastasis). Tumor site stages III: PT (fixated/limited invasion;\>2-≥4cm+depth of invasion (DOI) \>10mm/\>4cm+DOI≥10mm); ipsilateral LN ≤3cm extranodal extension negative(ENE-) (except human papilloma virus \[HPV\]16+ oropharynx: invasive PT or LN\>6cm); IVA: PT (moderate invasion-to adjacent structures\[AS\]);bilateral/ipsilateral/contralateral LN≤6cm ENE-; IVB: PT (advanced invasion-beyond AS) or LN\>6cm ENE±. Higher numbers=more advanced cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Overall Cancer Staging at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          499
        title
        TPS <50%
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          210
        title
        TPS ≥50%
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry (IHC) assay using tumor tissue from a newly obtained biopsy. The number of participants with TPS \<50 and TPS ≥50 at baseline was presented. Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Ligand 1 (PD-L1) Status by Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        CPS <10
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          465
        title
        CPS ≥10
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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 \<10 and CPS ≥10 at baseline was presented. Participants with a CPS \<10 were classified as PD-L1 negative and participants with a CPS ≥10 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Status by Combined Positive Score (CPS; CPS10)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        CPS <1
      2. measurements
        1. group Id
          BG000
          value
          347
        2. group Id
          BG001
          value
          335
        3. group Id
          BG002
          value
          682
        title
        CPS ≥1
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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 \<1 and CPS ≥1 at baseline was 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 Status by CPS (CPS1)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      363
    2. group Id
      BG001
      value
      351
    3. group Id
      BG002
      value
      714
    units
    Participants
groups
  1. description
    Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    BG000
    title
    Pembrolizumab + Standard of Care (SOC)
  2. description
    Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    BG001
    title
    Standard of Care (SOC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.0
          value
          59.4
        2. group Id
          BG001
          spread
          10.0
          value
          60.6
        3. group Id
          BG002
          spread
          10.0
          value
          59.9
    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
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          151
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          286
        2. group Id
          BG001
          value
          277
        3. group Id
          BG002
          value
          563
        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
          55
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          101
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          598
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          95
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          284
        2. group Id
          BG001
          value
          270
        3. group Id
          BG002
          value
          554
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          29
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        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
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Oropharynx
      2. measurements
        1. group Id
          BG000
          value
          219
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          432
        title
        Oral Cavity
      3. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          154
        title
        Larynx
      4. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          54
        title
        Hypopharynx
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    The primary tumor site was categorized as tumor in oropharynx, oral cavity, larynx, and hypopharynx. The number of participants with tumor at each site at baseline was presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Tumor Site
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          183
        title
        III
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          528
        title
        IVA
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        IVB
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    American Joint Committee on Cancer 8th edition TNM stratified (PT=primary tumor \[size \& invasion of nearby tissue\], LN=cancerous lymph nodes, Met=distant metastasis). Tumor site stages III: PT (fixated/limited invasion;\>2-≥4cm+depth of invasion (DOI) \>10mm/\>4cm+DOI≥10mm); ipsilateral LN ≤3cm extranodal extension negative(ENE-) (except human papilloma virus \[HPV\]16+ oropharynx: invasive PT or LN\>6cm); IVA: PT (moderate invasion-to adjacent structures\[AS\]);bilateral/ipsilateral/contralateral LN≤6cm ENE-; IVB: PT (advanced invasion-beyond AS) or LN\>6cm ENE±. Higher numbers=more advanced cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Overall Cancer Staging at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          499
        title
        TPS <50%
      2. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          210
        title
        TPS ≥50%
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Missing
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry (IHC) assay using tumor tissue from a newly obtained biopsy. The number of participants with TPS \<50 and TPS ≥50 at baseline was presented. Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Ligand 1 (PD-L1) Status by Tumor Proportion Score (TPS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        CPS <10
      2. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          465
        title
        CPS ≥10
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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 \<10 and CPS ≥10 at baseline was presented. Participants with a CPS \<10 were classified as PD-L1 negative and participants with a CPS ≥10 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Status by Combined Positive Score (CPS; CPS10)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
        title
        CPS <1
      2. measurements
        1. group Id
          BG000
          value
          347
        2. group Id
          BG001
          value
          335
        3. group Id
          BG002
          value
          682
        title
        CPS ≥1
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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 \<1 and CPS ≥1 at baseline was 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 Status by CPS (CPS1)
    unit Of Measure
    Participants

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