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NCT02362594 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) · Source last updated 2026-03-05

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

groups
  1. description
    In Part 1, participants received pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year.
    id
    FG000
    title
    Pembrolizumab
  2. description
    In Part 1, participants received placebo IV as post-surgery therapy Q3W.
    id
    FG001
    title
    Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        514
      2. group Id
        FG001
        num Subjects
        505
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        509
      2. group Id
        FG001
        num Subjects
        502
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        21
      type
      Continuing Part 1 Adjuvant Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        264
      2. group Id
        FG001
        num Subjects
        280
      comment
      Completed Part 1 Adjuvant Therapy
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        225
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
As of the 02-Oct-2017 interim database cut-off date, of the 1019 randomized participants in Part 1, 544 had completed Part 1 and 62 were continuing in Part 1. This interim results disclosure is for Part 1 only.
Complete source fields
groups
  1. description
    In Part 1, participants received pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year.
    id
    FG000
    title
    Pembrolizumab
  2. description
    In Part 1, participants received placebo IV as post-surgery therapy Q3W.
    id
    FG001
    title
    Placebo
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        514
      2. group Id
        FG001
        num Subjects
        505
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        509
      2. group Id
        FG001
        num Subjects
        502
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        21
      type
      Continuing Part 1 Adjuvant Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        264
      2. group Id
        FG001
        num Subjects
        280
      comment
      Completed Part 1 Adjuvant Therapy
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        250
      2. group Id
        FG001
        num Subjects
        225
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
As of the 02-Oct-2017 interim database cut-off date, of the 1019 randomized participants in Part 1, 544 had completed Part 1 and 62 were continuing in Part 1. This interim results disclosure is for Part 1 only.

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Preserved source evidence · Not medical advice