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NCT03635567 · BASELINE

Baseline characteristics

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) · Source last updated 2026-02-04

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
      308
    2. group Id
      BG001
      value
      309
    3. group Id
      BG002
      value
      617
    units
    Participants
groups
  1. description
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab+Chemotherapy
  2. description
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    id
    BG001
    title
    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
          11.9
          value
          51.7
        2. group Id
          BG001
          spread
          12.7
          value
          50.7
        3. group Id
          BG002
          spread
          12.3
          value
          51.2
    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
          308
        2. group Id
          BG001
          value
          309
        3. group Id
          BG002
          value
          617
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          109
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          230
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          377
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        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
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          110
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          170
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          360
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          66
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        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
          34
        3. group Id
          BG002
          value
          69
      title
      PD-L1 CPS<1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          231
      title
      1≤ PD-L1 CPS<10
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          317
      title
      PD-L1 CPS≥10
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue. Randomization of participants in the study were stratified by their PD-L1 CPS at baseline (PD-L1 CPS\<1, 1≤ PD-L1 CPS\<10, or PD-L1 CPS≥10).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          190
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          427
      title
      No
    description
    Randomization of participants was stratified by whether they were metastatic at initial diagnosis (Yes or No). Metastatic was defined as Stage IVB based on the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) (2009).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic at Initial Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          389
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          228
      title
      No
    description
    Randomization of participants was stratified by the Investigator's choice for the participant to receive bevacizumab (Yes or No).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice to Use Bevacizumab
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      308
    2. group Id
      BG001
      value
      309
    3. group Id
      BG002
      value
      617
    units
    Participants
groups
  1. description
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab+Chemotherapy
  2. description
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    id
    BG001
    title
    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
          11.9
          value
          51.7
        2. group Id
          BG001
          spread
          12.7
          value
          50.7
        3. group Id
          BG002
          spread
          12.3
          value
          51.2
    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
          308
        2. group Id
          BG001
          value
          309
        3. group Id
          BG002
          value
          617
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          109
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          230
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          193
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          377
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        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
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          110
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          170
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          360
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          66
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        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
          34
        3. group Id
          BG002
          value
          69
      title
      PD-L1 CPS<1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          231
      title
      1≤ PD-L1 CPS<10
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          317
      title
      PD-L1 CPS≥10
    description
    Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue. Randomization of participants in the study were stratified by their PD-L1 CPS at baseline (PD-L1 CPS\<1, 1≤ PD-L1 CPS\<10, or PD-L1 CPS≥10).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          190
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          427
      title
      No
    description
    Randomization of participants was stratified by whether they were metastatic at initial diagnosis (Yes or No). Metastatic was defined as Stage IVB based on the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) (2009).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic at Initial Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          389
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          228
      title
      No
    description
    Randomization of participants was stratified by the Investigator's choice for the participant to receive bevacizumab (Yes or No).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice to Use Bevacizumab
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice