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NCT04221945 · BASELINE

Baseline characteristics

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047) · Source last updated 2026-02-20

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
      529
    2. group Id
      BG001
      value
      531
    3. group Id
      BG002
      value
      1060
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    BG000
    title
    Chemoradiotherapy + Pembrolizumab
  2. description
    Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    BG001
    title
    Chemoradiotherapy + Placebo for Pembrolizumab
  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
          49.4
        2. group Id
          BG001
          spread
          12.3
          value
          50.1
        3. group Id
          BG002
          spread
          12.1
          value
          49.8
    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
          529
        2. group Id
          BG001
          value
          531
        3. group Id
          BG002
          value
          1060
        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
          161
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          334
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          363
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          719
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        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
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          304
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          518
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          164
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          22
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          50
      title
      CPS<1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          502
        2. group Id
          BG001
          value
          498
        3. group Id
          BG002
          value
          1000
      title
      CPS>=1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Missing
    description
    Programmed cell death ligand 1 (PDL-1) status based on combined positive score (CPS) 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 CS \<1 were classified as PD-L1 negative, and participants with CPS ≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PDL-1 Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      529
    2. group Id
      BG001
      value
      531
    3. group Id
      BG002
      value
      1060
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    BG000
    title
    Chemoradiotherapy + Pembrolizumab
  2. description
    Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
    id
    BG001
    title
    Chemoradiotherapy + Placebo for Pembrolizumab
  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
          49.4
        2. group Id
          BG001
          spread
          12.3
          value
          50.1
        3. group Id
          BG002
          spread
          12.1
          value
          49.8
    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
          529
        2. group Id
          BG001
          value
          531
        3. group Id
          BG002
          value
          1060
        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
          161
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          334
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          363
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          719
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        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
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          304
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          264
        3. group Id
          BG002
          value
          518
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          164
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          22
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          50
      title
      CPS<1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          502
        2. group Id
          BG001
          value
          498
        3. group Id
          BG002
          value
          1000
      title
      CPS>=1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Missing
    description
    Programmed cell death ligand 1 (PDL-1) status based on combined positive score (CPS) 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 CS \<1 were classified as PD-L1 negative, and participants with CPS ≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PDL-1 Status
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice