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NCT03278782 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin · Source last updated 2026-09-30

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

groups
  1. description
    Pembrolizumab 200mg IV D1 + Romidepsin 14mg/m² IV D1, D8 q21d
    id
    FG000
    title
    Cohort 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This is a phase Ib/II study- and so there is no dose escalation- it was more safety run-in for Ib followed by phase II. There is only one arm since this is a single arm trial.
Complete source fields
groups
  1. description
    Pembrolizumab 200mg IV D1 + Romidepsin 14mg/m² IV D1, D8 q21d
    id
    FG000
    title
    Cohort 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Progressive Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This is a phase Ib/II study- and so there is no dose escalation- it was more safety run-in for Ib followed by phase II. There is only one arm since this is a single arm trial.

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Preserved source evidence · Not medical advice