Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02178722 · BASELINE

Baseline characteristics

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers · Source last updated 2022-02-14

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
      4
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      382
    6. group Id
      BG005
      value
      444
    units
    Participants
groups
  1. description
    Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG000
    title
    Phase 1: Epacadostat 25 mg BID
  2. description
    Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG001
    title
    Phase 1: Epacadostat 50 mg BID
  3. description
    Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG002
    title
    Phase 1: Epacadostat 100 mg BID
  4. description
    Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG003
    title
    Phase 1: Epacadostat 300 mg BID
  5. description
    Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
    id
    BG004
    title
    Phase 2: Epacadostat 100 mg BID
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.01
          value
          48.8
        2. group Id
          BG001
          spread
          12.97
          value
          60.8
        3. group Id
          BG002
          spread
          13.67
          value
          63.2
        4. group Id
          BG003
          spread
          13.06
          value
          59.2
        5. group Id
          BG004
          spread
          11.60
          value
          62.7
        6. group Id
          BG005
          spread
          11.92
          value
          62.3
    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
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          181
        6. group Id
          BG005
          value
          208
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          201
        6. group Id
          BG005
          value
          236
        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
          1
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          337
        6. group Id
          BG005
          value
          393
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          22
      title
      Black/African-American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          17
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        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
          1
      title
      Native Hawaiian/Pacific Islander
    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
          9
        6. group Id
          BG005
          value
          9
      title
      Other
    6. 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
          2
        6. group Id
          BG005
          value
          2
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    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
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          18
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          353
        6. group Id
          BG005
          value
          413
      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
          10
        6. group Id
          BG005
          value
          10
      title
      Unknown
    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
          2
        6. group Id
          BG005
          value
          2
      title
      Other
    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
          1
        6. group Id
          BG005
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      382
    6. group Id
      BG005
      value
      444
    units
    Participants
groups
  1. description
    Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG000
    title
    Phase 1: Epacadostat 25 mg BID
  2. description
    Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG001
    title
    Phase 1: Epacadostat 50 mg BID
  3. description
    Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG002
    title
    Phase 1: Epacadostat 100 mg BID
  4. description
    Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    BG003
    title
    Phase 1: Epacadostat 300 mg BID
  5. description
    Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
    id
    BG004
    title
    Phase 2: Epacadostat 100 mg BID
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.01
          value
          48.8
        2. group Id
          BG001
          spread
          12.97
          value
          60.8
        3. group Id
          BG002
          spread
          13.67
          value
          63.2
        4. group Id
          BG003
          spread
          13.06
          value
          59.2
        5. group Id
          BG004
          spread
          11.60
          value
          62.7
        6. group Id
          BG005
          spread
          11.92
          value
          62.3
    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
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          181
        6. group Id
          BG005
          value
          208
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          201
        6. group Id
          BG005
          value
          236
        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
          1
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          337
        6. group Id
          BG005
          value
          393
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          22
      title
      Black/African-American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          17
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        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
          1
      title
      Native Hawaiian/Pacific Islander
    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
          9
        6. group Id
          BG005
          value
          9
      title
      Other
    6. 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
          2
        6. group Id
          BG005
          value
          2
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    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
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          18
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          353
        6. group Id
          BG005
          value
          413
      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
          10
        6. group Id
          BG005
          value
          10
      title
      Unknown
    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
          2
        6. group Id
          BG005
          value
          2
      title
      Other
    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
          1
        6. group Id
          BG005
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice