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NCT02054806 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) · Source last updated 2023-10-30

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

groups
  1. description
    Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
    id
    FG000
    title
    Pembrolizumab 10 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      type
      Sponsor Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        43
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        391
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        477
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        475
      type
      Treated During First Course
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Treated During Second Course
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        477
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively. Per protocol, analyses of disease type cohort was planned and conducted for efficacy outcome measures only.
recruitment Details
Participants with a histologically- or cytologically-confirmed diagnosis of 20 advanced (unresectable and/or metastatic) solid tumors, were recruited into a single arm.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study.
    id
    FG000
    title
    Pembrolizumab 10 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        31
      type
      Sponsor Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        43
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        391
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        477
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        475
      type
      Treated During First Course
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      Treated During Second Course
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        477
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively. Per protocol, analyses of disease type cohort was planned and conducted for efficacy outcome measures only.
recruitment Details
Participants with a histologically- or cytologically-confirmed diagnosis of 20 advanced (unresectable and/or metastatic) solid tumors, were recruited into a single arm.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice