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NCT04003636 · BASELINE

Baseline characteristics

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) · Source last updated 2026-03-24

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
      533
    2. group Id
      BG001
      value
      536
    3. group Id
      BG002
      value
      1069
    units
    Participants
groups
  1. description
    Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
    id
    BG000
    title
    Arm A: Pembrolizumab + Chemotherapy
  2. description
    Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
    id
    BG001
    title
    Arm B: Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          63.3
        2. group Id
          BG001
          spread
          11.0
          value
          61.8
        3. group Id
          BG002
          spread
          10.7
          value
          62.5
    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
          253
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          517
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          280
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          552
        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
          59
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          111
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          433
        2. group Id
          BG001
          value
          449
        3. group Id
          BG002
          value
          882
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          76
        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
          1
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          495
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          256
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          524
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
        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
          242
        2. group Id
          BG001
          value
          244
        3. group Id
          BG002
          value
          486
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          291
        2. group Id
          BG001
          value
          292
        3. group Id
          BG002
          value
          583
      title
      Non-Asian
    description
    Randomization of participants was stratified by geographic region of the enrolling site (Asia or non-Asia).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          126
      title
      Locally Advanced
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          473
        2. group Id
          BG001
          value
          470
        3. group Id
          BG002
          value
          943
      title
      Metastatic
    description
    Randomization of participants was stratified by disease status as locally advanced or metastatic.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          233
      title
      Gallbladder
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          320
        2. group Id
          BG001
          value
          313
        3. group Id
          BG002
          value
          633
      title
      Intrahepatic
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          203
      title
      Extrahepatic
    description
    Randomization of participants was stratified by location of tumor as gallbladder or intrahepatic or extrahepatic bile duct cancers.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Origin
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      533
    2. group Id
      BG001
      value
      536
    3. group Id
      BG002
      value
      1069
    units
    Participants
groups
  1. description
    Participants received pembrolizumab, 200 mg intravenous (IV) infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, IV infusion Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab 200mg IV Q3W, Day 1 of each 3-week cycle for up to 17 cycles. Treatment with Gemcitabine could have been stopped at any time in first or second course due to toxicity or disease progression.
    id
    BG000
    title
    Arm A: Pembrolizumab + Chemotherapy
  2. description
    Participants received Placebo to Pembrolizumab, 200 mg IV infusion, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2 IV infusion, Q3W, Day 1 and Day 8 of each 3-week cycle for up to 8 cycles.
    id
    BG001
    title
    Arm B: Placebo + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          63.3
        2. group Id
          BG001
          spread
          11.0
          value
          61.8
        3. group Id
          BG002
          spread
          10.7
          value
          62.5
    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
          253
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          517
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          280
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          552
        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
          59
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          111
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          433
        2. group Id
          BG001
          value
          449
        3. group Id
          BG002
          value
          882
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          76
        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
          1
        3. group Id
          BG002
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          250
        3. group Id
          BG002
          value
          495
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          256
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          524
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
        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
          242
        2. group Id
          BG001
          value
          244
        3. group Id
          BG002
          value
          486
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          291
        2. group Id
          BG001
          value
          292
        3. group Id
          BG002
          value
          583
      title
      Non-Asian
    description
    Randomization of participants was stratified by geographic region of the enrolling site (Asia or non-Asia).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          126
      title
      Locally Advanced
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          473
        2. group Id
          BG001
          value
          470
        3. group Id
          BG002
          value
          943
      title
      Metastatic
    description
    Randomization of participants was stratified by disease status as locally advanced or metastatic.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          233
      title
      Gallbladder
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          320
        2. group Id
          BG001
          value
          313
        3. group Id
          BG002
          value
          633
      title
      Intrahepatic
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          203
      title
      Extrahepatic
    description
    Randomization of participants was stratified by location of tumor as gallbladder or intrahepatic or extrahepatic bile duct cancers.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of Origin
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice