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NCT03142334 · FLOW

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Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564) · Source last updated 2026-03-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        33
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        463
      2. group Id
        FG001
        num Subjects
        454
      type
      Ongoing on trial follow up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        488
      2. group Id
        FG001
        num Subjects
        496
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Continuing Study Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        298
      2. group Id
        FG001
        num Subjects
        365
      type
      Completed Study Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        190
      2. group Id
        FG001
        num Subjects
        130
      type
      Discontinued Study Treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed Trial
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 994 participants randomized in the study, 984 participants received study medication and were evaluable for safety analyses (Database cutoff date 14 Dec 2020)
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        33
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        11
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        463
      2. group Id
        FG001
        num Subjects
        454
      type
      Ongoing on trial follow up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        488
      2. group Id
        FG001
        num Subjects
        496
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Continuing Study Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        298
      2. group Id
        FG001
        num Subjects
        365
      type
      Completed Study Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        190
      2. group Id
        FG001
        num Subjects
        130
      type
      Discontinued Study Treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed Trial
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 994 participants randomized in the study, 984 participants received study medication and were evaluable for safety analyses (Database cutoff date 14 Dec 2020)

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