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NCT03698019 · FLOW

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A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma · Source last updated 2026-08-04

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

groups
  1. description
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    FG000
    title
    Arm I (Adjuvant Pembrolizumab)
  2. description
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    FG001
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      type
      Still receiving protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Co-morbidities
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Scheduling Issues
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant Refusal
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        127
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Step 1: Registration
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant Refusal
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Neoadjuvant Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        9
      type
      Metastatic Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Residual Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Trial Closed due to Covid-19
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Concerns about Exposure to Covid-19
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Disease other than melanoma identified at surgery
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Radiotherapy-related Delays
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        127
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        109
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Step 2: Surgery
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        33
      type
      Still receiving protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        9
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        16
      type
      Other, unspecified reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        109
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        50
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        59
      type
      NOT COMPLETED
    title
    Step 3: Adjuvant Pembrolizumab
pre Assignment Details
Three hundred forty-five participants were assessed for eligibility. Thirty-two participants were deemed ineligible for either not having measurable disease, per RECIST criteria (27 participants), or having an ineligible disease stage (5). The remaining 313 eligible participants were randomized.
Complete source fields
groups
  1. description
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    FG000
    title
    Arm I (Adjuvant Pembrolizumab)
  2. description
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    FG001
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      type
      Still receiving protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Toxicity
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        12
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Co-morbidities
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Scheduling Issues
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant Refusal
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        159
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        127
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        27
      type
      NOT COMPLETED
    title
    Step 1: Registration
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant Refusal
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Neoadjuvant Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        9
      type
      Metastatic Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Residual Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Trial Closed due to Covid-19
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Concerns about Exposure to Covid-19
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Disease other than melanoma identified at surgery
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Radiotherapy-related Delays
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        127
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        109
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        18
      type
      NOT COMPLETED
    title
    Step 2: Surgery
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        33
      type
      Still receiving protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        9
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        16
      type
      Other, unspecified reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        109
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        50
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        59
      type
      NOT COMPLETED
    title
    Step 3: Adjuvant Pembrolizumab
pre Assignment Details
Three hundred forty-five participants were assessed for eligibility. Thirty-two participants were deemed ineligible for either not having measurable disease, per RECIST criteria (27 participants), or having an ineligible disease stage (5). The remaining 313 eligible participants were randomized.

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

Preserved source evidence · Not medical advice