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NCT03615326 · BASELINE

Baseline characteristics

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) · Source last updated 2026-08-26

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
      350
    2. group Id
      BG001
      value
      348
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      738
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
    id
    BG000
    title
    Global Pembrolizumab + Standard of Care First Course
  2. description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    id
    BG001
    title
    Global Standard of Care
  3. description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    BG002
    title
    Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
  4. description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    BG003
    title
    Japan Trastuzumab + S-1 Plus Oxaliplatin
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          60.4
        2. group Id
          BG001
          spread
          10.8
          value
          61.7
        3. group Id
          BG002
          spread
          12.8
          value
          66.1
        4. group Id
          BG003
          spread
          6.8
          value
          64.1
        5. group Id
          BG004
          spread
          11.3
          value
          61.2
    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
          66
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          142
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          284
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          596
        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
          38
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          85
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          293
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          640
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          13
        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
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          280
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          430
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        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
          113
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          224
      title
      Western Europe/Israel/North America/Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          237
      title
      Asia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          237
      title
      Rest of the World
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          40
      title
      Japan
    description
    Per protocol, participants in the Global Cohort were stratified by geographic region using the following categories: Western Europe/Israel/North America/Australia; Asia; and Rest of World. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by geographic region.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          298
        2. group Id
          BG001
          value
          296
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          627
      title
      CPS≥1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          111
      title
      CPS<1
    description
    PD-L1 combined positive score (CPS) at baseline was determined by immunohistochemistry (IHC) using an archival tumor sample. 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. Per protocol, participants in both the Global Cohort and Japan-specific SOX Cohort were stratified by PD-L1 CPS status at baseline.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          102
      title
      FP (cisplatin plus 5 fluorouracil)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          299
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          596
      title
      CAPOX (capecitabine and oxaliplatin)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          40
      title
      SOX (S-1 plus oxaliplatin)
    description
    Per protocol, participants in the Global Cohort were stratified by chemotherapy regimen. Chemotherapy regimen options were FP: cisplatin plus 5-fluorouracil (5-FU) or CAPOX: capecitabine and oxaliplatin. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by chemotherapy regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chemotherapy Regimen
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      350
    2. group Id
      BG001
      value
      348
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      738
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy. Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
    id
    BG000
    title
    Global Pembrolizumab + Standard of Care First Course
  2. description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    id
    BG001
    title
    Global Standard of Care
  3. description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    BG002
    title
    Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
  4. description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    BG003
    title
    Japan Trastuzumab + S-1 Plus Oxaliplatin
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          60.4
        2. group Id
          BG001
          spread
          10.8
          value
          61.7
        3. group Id
          BG002
          spread
          12.8
          value
          66.1
        4. group Id
          BG003
          spread
          6.8
          value
          64.1
        5. group Id
          BG004
          spread
          11.3
          value
          61.2
    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
          66
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          142
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          284
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          596
        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
          38
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          85
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          293
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          640
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          13
        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
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          280
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          218
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          430
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        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
          113
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          224
      title
      Western Europe/Israel/North America/Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          237
      title
      Asia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          237
      title
      Rest of the World
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          40
      title
      Japan
    description
    Per protocol, participants in the Global Cohort were stratified by geographic region using the following categories: Western Europe/Israel/North America/Australia; Asia; and Rest of World. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by geographic region.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          298
        2. group Id
          BG001
          value
          296
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          627
      title
      CPS≥1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          111
      title
      CPS<1
    description
    PD-L1 combined positive score (CPS) at baseline was determined by immunohistochemistry (IHC) using an archival tumor sample. 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. Per protocol, participants in both the Global Cohort and Japan-specific SOX Cohort were stratified by PD-L1 CPS status at baseline.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          102
      title
      FP (cisplatin plus 5 fluorouracil)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          299
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          596
      title
      CAPOX (capecitabine and oxaliplatin)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          40
      title
      SOX (S-1 plus oxaliplatin)
    description
    Per protocol, participants in the Global Cohort were stratified by chemotherapy regimen. Chemotherapy regimen options were FP: cisplatin plus 5-fluorouracil (5-FU) or CAPOX: capecitabine and oxaliplatin. Per protocol, participants in the Japan-specific SOX Cohort were not stratified by chemotherapy regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chemotherapy Regimen
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice