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NCT02702414 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224) · Source last updated 2024-09-04

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

groups
  1. description
    Participants with previously systemically treated HCC received a pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    FG000
    title
    Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib
  2. description
    Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    FG001
    title
    Cohort 2: HCC-Systemic Therapy Naïve
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        51
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        104
      2. group Id
        FG001
        num Subjects
        51
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, final analyses of all outcome measures were planned to be performed during the first course of therapy and collection of adverse events and all-cause mortality were planned to be done in both first and second courses.
recruitment Details
This study had 2 cohorts with each cohort starting treatment at a different time period during the study. One participant allocated to Cohort 1 withdrew from the study before receiving treatment. This participant was not eligible for safety or efficacy analysis.
Complete source fields
groups
  1. description
    Participants with previously systemically treated HCC received a pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    FG000
    title
    Cohort 1: Hepatocellular Carcinoma (HCC)-Prior Systemic Therapy With Sorafenib
  2. description
    Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
    id
    FG001
    title
    Cohort 2: HCC-Systemic Therapy Naïve
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        42
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        7
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        51
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        104
      2. group Id
        FG001
        num Subjects
        51
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        105
      2. group Id
        FG001
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Per protocol, final analyses of all outcome measures were planned to be performed during the first course of therapy and collection of adverse events and all-cause mortality were planned to be done in both first and second courses.
recruitment Details
This study had 2 cohorts with each cohort starting treatment at a different time period during the study. One participant allocated to Cohort 1 withdrew from the study before receiving treatment. This participant was not eligible for safety or efficacy analysis.

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Preserved source evidence · Not medical advice