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NCT02500797 · BASELINE

Baseline characteristics

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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
      43
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      15
    4. group Id
      BG003
      value
      14
    5. group Id
      BG004
      value
      14
    6. group Id
      BG005
      value
      15
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      11
    9. group Id
      BG008
      value
      164
    units
    Participants
groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Initial Single
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Initial Dual
  3. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    LPS Single
  4. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG003
    title
    LPS Dual
  5. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    UPS/MFH Single
  6. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG005
    title
    UPS/MFH Dual
  7. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG006
    title
    GIST Single
  8. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG007
    title
    GIST Dual
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21.0
          upper Limit
          76.0
          value
          56.0
        2. group Id
          BG001
          lower Limit
          27.0
          upper Limit
          81.0
          value
          57.0
        3. group Id
          BG002
          lower Limit
          27.0
          upper Limit
          82.0
          value
          62.0
        4. group Id
          BG003
          lower Limit
          46.0
          upper Limit
          68.0
          value
          58.5
        5. group Id
          BG004
          lower Limit
          34.0
          upper Limit
          85.0
          value
          63.5
        6. group Id
          BG005
          lower Limit
          44.0
          upper Limit
          84.0
          value
          60.0
        7. group Id
          BG006
          lower Limit
          41.0
          upper Limit
          79.0
          value
          69.0
        8. group Id
          BG007
          lower Limit
          40.0
          upper Limit
          81.0
          value
          62.0
        9. group Id
          BG008
          lower Limit
          27
          upper Limit
          85
          value
          62
    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
          21
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          77
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          87
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          142
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          90
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          74
        title
        1
    description
    Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
Randomized patients are included in this analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      43
    2. group Id
      BG001
      value
      42
    3. group Id
      BG002
      value
      15
    4. group Id
      BG003
      value
      14
    5. group Id
      BG004
      value
      14
    6. group Id
      BG005
      value
      15
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      11
    9. group Id
      BG008
      value
      164
    units
    Participants
groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Initial Single
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Initial Dual
  3. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    LPS Single
  4. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG003
    title
    LPS Dual
  5. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    UPS/MFH Single
  6. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG005
    title
    UPS/MFH Dual
  7. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    BG006
    title
    GIST Single
  8. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    BG007
    title
    GIST Dual
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21.0
          upper Limit
          76.0
          value
          56.0
        2. group Id
          BG001
          lower Limit
          27.0
          upper Limit
          81.0
          value
          57.0
        3. group Id
          BG002
          lower Limit
          27.0
          upper Limit
          82.0
          value
          62.0
        4. group Id
          BG003
          lower Limit
          46.0
          upper Limit
          68.0
          value
          58.5
        5. group Id
          BG004
          lower Limit
          34.0
          upper Limit
          85.0
          value
          63.5
        6. group Id
          BG005
          lower Limit
          44.0
          upper Limit
          84.0
          value
          60.0
        7. group Id
          BG006
          lower Limit
          41.0
          upper Limit
          79.0
          value
          69.0
        8. group Id
          BG007
          lower Limit
          40.0
          upper Limit
          81.0
          value
          62.0
        9. group Id
          BG008
          lower Limit
          27
          upper Limit
          85
          value
          62
    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
          21
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          77
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          87
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          12
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          142
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          90
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          74
        title
        1
    description
    Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
Randomized patients are included in this analysis.

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

Preserved source evidence · Not medical advice