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NCT02224781 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      135
    2. group Id
      BG001
      value
      132
    3. group Id
      BG002
      value
      267
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm B (BRAF Inhibitor Therapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          29
          upper Limit
          83
          value
          59
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          84
          value
          60
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          84
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          98
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          169
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Non-White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
All randomized patients
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      135
    2. group Id
      BG001
      value
      132
    3. group Id
      BG002
      value
      267
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm B (BRAF Inhibitor Therapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          29
          upper Limit
          83
          value
          59
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          84
          value
          60
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          84
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          98
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          83
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          169
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Non-White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
All randomized patients

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

Preserved source evidence · Not medical advice