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NCT03797326 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      type
      Sponsor Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        95
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        30
      6. group Id
        FG005
        num Subjects
        96
      7. group Id
        FG006
        num Subjects
        97
      8. group Id
        FG007
        num Subjects
        98
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Enrolled in error
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        102
      4. group Id
        FG003
        num Subjects
        107
      5. group Id
        FG004
        num Subjects
        32
      6. group Id
        FG005
        num Subjects
        102
      7. group Id
        FG006
        num Subjects
        103
      8. group Id
        FG007
        num Subjects
        103
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        99
      4. group Id
        FG003
        num Subjects
        105
      5. group Id
        FG004
        num Subjects
        30
      6. group Id
        FG005
        num Subjects
        101
      7. group Id
        FG006
        num Subjects
        102
      8. group Id
        FG007
        num Subjects
        103
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        102
      4. group Id
        FG003
        num Subjects
        107
      5. group Id
        FG004
        num Subjects
        32
      6. group Id
        FG005
        num Subjects
        102
      7. group Id
        FG006
        num Subjects
        103
      8. group Id
        FG007
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 85 centers in 17 countries.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    title
    Cohort G: Pancreatic Cancer (Lenva + Pembro)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      type
      Sponsor Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        95
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        30
      6. group Id
        FG005
        num Subjects
        96
      7. group Id
        FG006
        num Subjects
        97
      8. group Id
        FG007
        num Subjects
        98
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      type
      Enrolled in error
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        102
      4. group Id
        FG003
        num Subjects
        107
      5. group Id
        FG004
        num Subjects
        32
      6. group Id
        FG005
        num Subjects
        102
      7. group Id
        FG006
        num Subjects
        103
      8. group Id
        FG007
        num Subjects
        103
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        99
      4. group Id
        FG003
        num Subjects
        105
      5. group Id
        FG004
        num Subjects
        30
      6. group Id
        FG005
        num Subjects
        101
      7. group Id
        FG006
        num Subjects
        102
      8. group Id
        FG007
        num Subjects
        103
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        102
      4. group Id
        FG003
        num Subjects
        107
      5. group Id
        FG004
        num Subjects
        32
      6. group Id
        FG005
        num Subjects
        102
      7. group Id
        FG006
        num Subjects
        103
      8. group Id
        FG007
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 85 centers in 17 countries.

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

Preserved source evidence · Not medical advice