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NCT01848834 · FLOW

Participant flow

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012) · Source last updated 2021-06-28

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) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG000
    title
    Cohort A: Triple Negative Breast Cancer
  2. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG001
    title
    Cohort B: Head & Neck Cancer
  3. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG002
    title
    Cohort C: Urothelial Cancer
  4. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG003
    title
    Cohort D: Gastric Cancer
  5. description
    Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG004
    title
    Cohort B2: Head & Neck Cancer Expansion
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        9
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        27
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      type
      Excluded Medication
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        11
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Sponsor Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        36
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        33
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        132
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        60
      3. group Id
        FG002
        num Subjects
        33
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        132
      type
      Treated
    3. achievements
      1. comment
        Completed means two-year treatment completed
        group Id
        FG000
        num Subjects
        13
      2. comment
        Completed means two-year treatment completed
        group Id
        FG001
        num Subjects
        13
      3. comment
        Completed means two-year treatment completed
        group Id
        FG002
        num Subjects
        9
      4. comment
        Completed means two-year treatment completed
        group Id
        FG003
        num Subjects
        13
      5. comment
        Completed means two-year treatment completed
        group Id
        FG004
        num Subjects
        38
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        48
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        26
      5. group Id
        FG004
        num Subjects
        94
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All allocated participants through end of trial (EOT) analysis cutoff date of 30 June 2020.
Complete source fields
groups
  1. description
    Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG000
    title
    Cohort A: Triple Negative Breast Cancer
  2. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG001
    title
    Cohort B: Head & Neck Cancer
  3. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG002
    title
    Cohort C: Urothelial Cancer
  4. description
    Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG003
    title
    Cohort D: Gastric Cancer
  5. description
    Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
    id
    FG004
    title
    Cohort B2: Head & Neck Cancer Expansion
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        9
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        27
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      type
      Excluded Medication
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        11
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      type
      Sponsor Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        36
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        61
      3. group Id
        FG002
        num Subjects
        33
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        132
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        60
      3. group Id
        FG002
        num Subjects
        33
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        132
      type
      Treated
    3. achievements
      1. comment
        Completed means two-year treatment completed
        group Id
        FG000
        num Subjects
        13
      2. comment
        Completed means two-year treatment completed
        group Id
        FG001
        num Subjects
        13
      3. comment
        Completed means two-year treatment completed
        group Id
        FG002
        num Subjects
        9
      4. comment
        Completed means two-year treatment completed
        group Id
        FG003
        num Subjects
        13
      5. comment
        Completed means two-year treatment completed
        group Id
        FG004
        num Subjects
        38
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        48
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        26
      5. group Id
        FG004
        num Subjects
        94
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All allocated participants through end of trial (EOT) analysis cutoff date of 30 June 2020.

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

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