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NCT02903914 · BASELINE

Baseline characteristics

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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
      8
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      85
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      123
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      260
    units
    Participants
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    BG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG002
    title
    Part 1A and Part 2: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG003
    title
    Part 1A: INCB001158 150 mg
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
    id
    BG004
    title
    Part 1B: INCB001158 50 mg + Pembrolizumab
  6. description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    BG005
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    BG006
    title
    Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
  8. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
    id
    BG007
    title
    Part 1C: INCB001158 50 mg + Pembrolizumab
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.96
          value
          56.5
        2. group Id
          BG001
          spread
          6.10
          value
          61.7
        3. group Id
          BG002
          spread
          10.42
          value
          61.4
        4. group Id
          BG003
          spread
          8.12
          value
          67.0
        5. group Id
          BG004
          spread
          11.64
          value
          58.7
        6. group Id
          BG005
          spread
          10.81
          value
          62.8
        7. group Id
          BG006
          spread
          11.94
          value
          59.7
        8. group Id
          BG007
          spread
          7.69
          value
          73.3
        9. group Id
          BG008
          spread
          10.9
          value
          60.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          43
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          80
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          151
        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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          109
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          224
      title
      White or Causasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          18
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          10
      title
      Asian
    4. categories
      1. 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
      American Indican/Alaska Native
    5. categories
      1. 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
      Native Hawaiian or Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
      title
      Captured as "Other" in Database
    7. categories
      1. 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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          114
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          237
      title
      Not Hispanic or Latino
    3. categories
      1. 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
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      8
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      85
    4. group Id
      BG003
      value
      7
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      123
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      260
    units
    Participants
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    BG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG002
    title
    Part 1A and Part 2: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    BG003
    title
    Part 1A: INCB001158 150 mg
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
    id
    BG004
    title
    Part 1B: INCB001158 50 mg + Pembrolizumab
  6. description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    BG005
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    BG006
    title
    Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
  8. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
    id
    BG007
    title
    Part 1C: INCB001158 50 mg + Pembrolizumab
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.96
          value
          56.5
        2. group Id
          BG001
          spread
          6.10
          value
          61.7
        3. group Id
          BG002
          spread
          10.42
          value
          61.4
        4. group Id
          BG003
          spread
          8.12
          value
          67.0
        5. group Id
          BG004
          spread
          11.64
          value
          58.7
        6. group Id
          BG005
          spread
          10.81
          value
          62.8
        7. group Id
          BG006
          spread
          11.94
          value
          59.7
        8. group Id
          BG007
          spread
          7.69
          value
          73.3
        9. group Id
          BG008
          spread
          10.9
          value
          60.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          43
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          80
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          151
        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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          109
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          224
      title
      White or Causasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          18
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          10
      title
      Asian
    4. categories
      1. 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
      American Indican/Alaska Native
    5. categories
      1. 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
      Native Hawaiian or Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          7
      title
      Captured as "Other" in Database
    7. categories
      1. 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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          21
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          114
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          237
      title
      Not Hispanic or Latino
    3. categories
      1. 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
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          2
      title
      Missing
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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