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NCT03698019 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      159
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      313
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          88
          value
          62
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          90
          value
          64
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          90
          value
          64
    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
          48
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          110
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          203
        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
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          287
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          291
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          238
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          72
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing/Not Reported
    description
    Zubrod's performance-status scores range from 0 to 5, with higher scores indicating greater disability; a score of 0 indicates that the participant is fully active, 1 that the patient is restricted in strenuous activity but is ambulatory, and 2 that the participant is unable to work but is ambulatory and capable of self-care and up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Zubrod Performance Status Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          270
      title
      Low or Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      High
    description
    LDH denotes lactate dehydrogenase.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    LDH Level
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          126
      title
      IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          143
      title
      IIIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      IIID
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
      title
      IV
    description
    Stages are defined according to the American Joint Committee on Cancer 'Cancer Staging Manual', 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          296
      title
      Cutaneous or Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Acral
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
      title
      Mucosal
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Missing/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Melanoma Subtype
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          102
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          108
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          101
      title
      Unknown
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ulceration
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          79
      title
      Mutated
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          126
      title
      Wild-type
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          108
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BRAF Mutation Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          309
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous BRAF and MEK Adjuvant Therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          310
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Radiotherapy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      159
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      313
    units
    Participants
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
    BG000
    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
    BG001
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          88
          value
          62
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          90
          value
          64
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          90
          value
          64
    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
          48
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          110
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          203
        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
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          287
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          291
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          238
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          72
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Missing/Not Reported
    description
    Zubrod's performance-status scores range from 0 to 5, with higher scores indicating greater disability; a score of 0 indicates that the participant is fully active, 1 that the patient is restricted in strenuous activity but is ambulatory, and 2 that the participant is unable to work but is ambulatory and capable of self-care and up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Zubrod Performance Status Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          270
      title
      Low or Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      High
    description
    LDH denotes lactate dehydrogenase.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    LDH Level
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          126
      title
      IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          143
      title
      IIIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      IIID
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
      title
      IV
    description
    Stages are defined according to the American Joint Committee on Cancer 'Cancer Staging Manual', 8th edition.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          296
      title
      Cutaneous or Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
      title
      Acral
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
      title
      Mucosal
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Missing/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Melanoma Subtype
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          102
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          108
      title
      No
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          101
      title
      Unknown
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing/Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ulceration
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          79
      title
      Mutated
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          126
      title
      Wild-type
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          108
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BRAF Mutation Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          309
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous BRAF and MEK Adjuvant Therapy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          310
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Radiotherapy
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice