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NCT03517449 · BASELINE

Baseline characteristics

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) · Source last updated 2026-03-19

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
      411
    2. group Id
      BG001
      value
      416
    3. group Id
      BG002
      value
      827
    units
    Participants
groups
  1. description
    Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
    id
    BG000
    title
    Lenvatinib 20 mg + Pembrolizumab 200 mg
  2. description
    Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
    id
    BG001
    title
    Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.1
          value
          63.2
        2. group Id
          BG001
          spread
          9.2
          value
          63.8
        3. group Id
          BG002
          spread
          9.1
          value
          63.5
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        In utero
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Preterm newborn infants (gestational age < 37 wks)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Newborns (0-27 days)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Infants and toddlers (28 days-23 months)
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Children (2-11 years)
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Adolescents (12-17 years)
      7. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          410
        title
        Adults (18-64 years)
      8. measurements
        1. group Id
          BG000
          value
          205
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          415
        title
        From 65-84 years
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        85 years and over
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          411
        2. group Id
          BG001
          value
          416
        3. group Id
          BG002
          value
          827
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          132
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          597
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          98
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          177
        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
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          247
        3. group Id
          BG002
          value
          508
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          79
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          246
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          487
        title
        0 = Fully active; no performance restrictions
      2. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          340
        title
        1 = Limited activity, ambulant, can-do light work
    description
    The ECOG PS scale indicates increasing levels of disability, with 0 indicating fully active; 1, restricted in strenuous activity; 2, restricted in work activity but ambulatory and capable of self-care; 3, capable of limited self-care; 4, completely disabled; and 5, dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          363
        title
        Participants with pelvic radiation
      2. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          464
        title
        Participants without pelvic radiation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of pelvic radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          474
        title
        Region 1
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          353
        title
        Region 2
    description
    Participants in region 1 were included from Europe,USA,Canada,Australia,New Zealand,Israel. Participants in region 2 were included from rest of the world.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic region
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          351
        3. group Id
          BG002
          value
          697
        title
        Proficient MMR (pMMR)
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
        title
        Deficient (dMMR)
    description
    The mismatch repair system (MMR) is a crucial mechanism in DNA repair that identifies and corrects errors that occur during DNA replication and recombination. pMMR indicates that the MMR system is functioning properly, which is advantageous for maintaining genomic stability and reducing mutation accumulation. In contrast, dMMR signifies a deficiency in the MMR system, leading to increased mutation rates and a higher risk of tumorigenesis. pMMR and dMMR were based on actual MMR status defined by immunohistochemistry (IHC) performed on tumor tissue.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mismatch repair (MMR) status
    unit Of Measure
    Participants
population Description
The Intention-to-treat (ITT) population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      411
    2. group Id
      BG001
      value
      416
    3. group Id
      BG002
      value
      827
    units
    Participants
groups
  1. description
    Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
    id
    BG000
    title
    Lenvatinib 20 mg + Pembrolizumab 200 mg
  2. description
    Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
    id
    BG001
    title
    Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.1
          value
          63.2
        2. group Id
          BG001
          spread
          9.2
          value
          63.8
        3. group Id
          BG002
          spread
          9.1
          value
          63.5
    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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        In utero
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Preterm newborn infants (gestational age < 37 wks)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Newborns (0-27 days)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Infants and toddlers (28 days-23 months)
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Children (2-11 years)
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Adolescents (12-17 years)
      7. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          204
        3. group Id
          BG002
          value
          410
        title
        Adults (18-64 years)
      8. measurements
        1. group Id
          BG000
          value
          205
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          415
        title
        From 65-84 years
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        85 years and over
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          411
        2. group Id
          BG001
          value
          416
        3. group Id
          BG002
          value
          827
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          132
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          597
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          98
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          177
        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
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          247
        3. group Id
          BG002
          value
          508
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          79
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          246
        2. group Id
          BG001
          value
          241
        3. group Id
          BG002
          value
          487
        title
        0 = Fully active; no performance restrictions
      2. measurements
        1. group Id
          BG000
          value
          165
        2. group Id
          BG001
          value
          175
        3. group Id
          BG002
          value
          340
        title
        1 = Limited activity, ambulant, can-do light work
    description
    The ECOG PS scale indicates increasing levels of disability, with 0 indicating fully active; 1, restricted in strenuous activity; 2, restricted in work activity but ambulatory and capable of self-care; 3, capable of limited self-care; 4, completely disabled; and 5, dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          363
        title
        Participants with pelvic radiation
      2. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          464
        title
        Participants without pelvic radiation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior history of pelvic radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          474
        title
        Region 1
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          353
        title
        Region 2
    description
    Participants in region 1 were included from Europe,USA,Canada,Australia,New Zealand,Israel. Participants in region 2 were included from rest of the world.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic region
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          351
        3. group Id
          BG002
          value
          697
        title
        Proficient MMR (pMMR)
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
        title
        Deficient (dMMR)
    description
    The mismatch repair system (MMR) is a crucial mechanism in DNA repair that identifies and corrects errors that occur during DNA replication and recombination. pMMR indicates that the MMR system is functioning properly, which is advantageous for maintaining genomic stability and reducing mutation accumulation. In contrast, dMMR signifies a deficiency in the MMR system, leading to increased mutation rates and a higher risk of tumorigenesis. pMMR and dMMR were based on actual MMR status defined by immunohistochemistry (IHC) performed on tumor tissue.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mismatch repair (MMR) status
    unit Of Measure
    Participants
population Description
The Intention-to-treat (ITT) population included all randomized participants.

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Preserved source evidence · Not medical advice