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NCT02224781 · FLOW

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Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma · Source last updated 2026-08-28

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

groups
  1. description
    IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    FG000
    title
    Arm A (Immunotherapy)
  2. description
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
    id
    FG001
    title
    Arm B (BRAF Inhibitor Therapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Never start protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        18
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      type
      Disease progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        9
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      Reason unknown
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternative therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        132
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        132
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        131
      type
      NOT COMPLETED
    title
    Step 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        24
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      On treatment
    milestones
    1. achievements
      1. comment
        61 patients progressed in step 1, 29 of them enrolled to step 2. In addition, one patient who had no progression also enrolled to step 2.
        group Id
        FG000
        num Subjects
        30
      2. comment
        98 patients progressed in step 1, and 49 of them enrolled in step 2. In addition, 3 patients who had no progression also enrolled in step 2.
        group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Enrolled to Step 2
recruitment Details
The study was activated on July 13, 2015. The study was suspended between February 2 and April 11, 2016 due to a drug supply issue (acute shortage in the supply of Dabrafenib and Trametinib capsules) and closed to accrual on September 30, 2021 with a total accrual of 267 patients.
Complete source fields
groups
  1. description
    IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    FG000
    title
    Arm A (Immunotherapy)
  2. description
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
    id
    FG001
    title
    Arm B (BRAF Inhibitor Therapy)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Never start protocol therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        42
      2. group Id
        FG001
        num Subjects
        18
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        83
      type
      Disease progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        9
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      type
      Reason unknown
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternative therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        132
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        132
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        96
      2. group Id
        FG001
        num Subjects
        131
      type
      NOT COMPLETED
    title
    Step 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        24
      type
      Disease progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      On treatment
    milestones
    1. achievements
      1. comment
        61 patients progressed in step 1, 29 of them enrolled to step 2. In addition, one patient who had no progression also enrolled to step 2.
        group Id
        FG000
        num Subjects
        30
      2. comment
        98 patients progressed in step 1, and 49 of them enrolled in step 2. In addition, 3 patients who had no progression also enrolled in step 2.
        group Id
        FG001
        num Subjects
        52
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Enrolled to Step 2
recruitment Details
The study was activated on July 13, 2015. The study was suspended between February 2 and April 11, 2016 due to a drug supply issue (acute shortage in the supply of Dabrafenib and Trametinib capsules) and closed to accrual on September 30, 2021 with a total accrual of 267 patients.

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Preserved source evidence · Not medical advice