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NCT02563002 · FLOW

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Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) · Source last updated 2024-10-03

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 intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    FG001
    title
    Standard of Care (SOC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        87
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        55
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        143
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      Switched Over to Pembrolizumab
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 307 participants randomized in the study, 296 participants received study medication and were evaluable for safety analyses.
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    FG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    FG001
    title
    Standard of Care (SOC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        72
      2. group Id
        FG001
        num Subjects
        87
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        74
      2. group Id
        FG001
        num Subjects
        55
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        143
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Received Second Course of Pembrolizumab
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        7
      type
      Switched Over to Pembrolizumab
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 307 participants randomized in the study, 296 participants received study medication and were evaluable for safety analyses.

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