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NCT03797326 · BASELINE

Baseline characteristics

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) · Source last updated 2026-05-04

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
      31
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      102
    4. group Id
      BG003
      value
      107
    5. group Id
      BG004
      value
      32
    6. group Id
      BG005
      value
      102
    7. group Id
      BG006
      value
      103
    8. group Id
      BG007
      value
      103
    9. group Id
      BG008
      value
      611
    units
    Participants
groups
  1. description
    Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
  2. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG001
    title
    Cohort B: Ovarian Cancer (Lenva + Pembro)
  3. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG002
    title
    Cohort C: Gastric Cancer (Lenva + Pembro)
  4. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG003
    title
    Cohort D1: Colorectal Cancer (Lenva + Pembro)
  5. description
    Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG004
    title
    Cohort D2: Colorectal Cancer (Lenva)
  6. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG005
    title
    Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
  7. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG006
    title
    Cohort F: Biliary Tract Cancer (Lenva + Pembro)
  8. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG007
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          71
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          83
        7. group Id
          BG006
          value
          52
        8. group Id
          BG007
          value
          56
        9. group Id
          BG008
          value
          398
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          51
        8. group Id
          BG007
          value
          47
        9. group Id
          BG008
          value
          213
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          53
        8. group Id
          BG007
          value
          42
        9. group Id
          BG008
          value
          271
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          75
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          64
        7. group Id
          BG006
          value
          50
        8. group Id
          BG007
          value
          61
        9. group Id
          BG008
          value
          340
        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
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          16
        9. group Id
          BG008
          value
          91
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          77
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          73
        7. group Id
          BG006
          value
          76
        8. group Id
          BG007
          value
          86
        9. group Id
          BG008
          value
          441
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          79
        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
          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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          17
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          82
        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
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          71
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          71
        8. group Id
          BG007
          value
          90
        9. group Id
          BG008
          value
          444
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          13
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          60
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      102
    4. group Id
      BG003
      value
      107
    5. group Id
      BG004
      value
      32
    6. group Id
      BG005
      value
      102
    7. group Id
      BG006
      value
      103
    8. group Id
      BG007
      value
      103
    9. group Id
      BG008
      value
      611
    units
    Participants
groups
  1. description
    Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
  2. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG001
    title
    Cohort B: Ovarian Cancer (Lenva + Pembro)
  3. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG002
    title
    Cohort C: Gastric Cancer (Lenva + Pembro)
  4. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG003
    title
    Cohort D1: Colorectal Cancer (Lenva + Pembro)
  5. description
    Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG004
    title
    Cohort D2: Colorectal Cancer (Lenva)
  6. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG005
    title
    Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
  7. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG006
    title
    Cohort F: Biliary Tract Cancer (Lenva + Pembro)
  8. description
    Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
    id
    BG007
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          71
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          83
        7. group Id
          BG006
          value
          52
        8. group Id
          BG007
          value
          56
        9. group Id
          BG008
          value
          398
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          51
        8. group Id
          BG007
          value
          47
        9. group Id
          BG008
          value
          213
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          32
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          38
        7. group Id
          BG006
          value
          53
        8. group Id
          BG007
          value
          42
        9. group Id
          BG008
          value
          271
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          75
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          64
        7. group Id
          BG006
          value
          50
        8. group Id
          BG007
          value
          61
        9. group Id
          BG008
          value
          340
        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
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          16
        9. group Id
          BG008
          value
          91
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          64
        4. group Id
          BG003
          value
          77
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          73
        7. group Id
          BG006
          value
          76
        8. group Id
          BG007
          value
          86
        9. group Id
          BG008
          value
          441
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          79
        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
          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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          17
        7. group Id
          BG006
          value
          18
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          82
        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
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          71
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          71
        8. group Id
          BG007
          value
          90
        9. group Id
          BG008
          value
          444
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          13
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          13
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          60
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice