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NCT06099782 · FLOW

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A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) · Source last updated 2026-04-08

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

groups
  1. description
    In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa subcutaneously (SC) for three 21-day cycles, followed by pembrolizumab intravenously (IV) for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
    id
    FG000
    title
    Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
  2. description
    In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
    id
    FG001
    title
    Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        76
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Pembrolizumab (+) Berahyaluronidase Alfa SC
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        76
      type
      Received Pembrolizumab IV
    4. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        70
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Treatment Crossover Period 1: Cycles 1-3
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        70
      type
      Received Pembrolizumab (+) Berahyaluronidase Alfa SC
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Pembrolizumab IV
    4. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Treatment Crossover Period 2: Cycles 4-6
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        56
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      NOT COMPLETED
    title
    Treatment Continuation Period
pre Assignment Details
147 participants were randomized to Treatment Arm A (n=71) or Treatment Arm B (n=76). Treatment Arms were defined per protocol as treatment sequence arms.
Complete source fields
groups
  1. description
    In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa subcutaneously (SC) for three 21-day cycles, followed by pembrolizumab intravenously (IV) for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
    id
    FG000
    title
    Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
  2. description
    In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
    id
    FG001
    title
    Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        76
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Pembrolizumab (+) Berahyaluronidase Alfa SC
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        76
      type
      Received Pembrolizumab IV
    4. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        70
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Treatment Crossover Period 1: Cycles 1-3
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
        1
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        70
      type
      Received Pembrolizumab (+) Berahyaluronidase Alfa SC
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Pembrolizumab IV
    4. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Treatment Crossover Period 2: Cycles 4-6
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        56
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        57
      2. group Id
        FG001
        num Subjects
        59
      type
      NOT COMPLETED
    title
    Treatment Continuation Period
pre Assignment Details
147 participants were randomized to Treatment Arm A (n=71) or Treatment Arm B (n=76). Treatment Arms were defined per protocol as treatment sequence arms.

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Preserved source evidence · Not medical advice