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NCT02327078 · BASELINE

Baseline characteristics

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204) · Source last updated 2025-08-14

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
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      83
    9. group Id
      BG008
      value
      176
    10. group Id
      BG009
      value
      307
    units
    Participants
groups
  1. description
    Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG000
    title
    Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
  2. description
    Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG001
    title
    Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
  3. description
    Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG002
    title
    Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
  4. description
    Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG003
    title
    Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
  5. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG004
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum
  6. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG005
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum
  7. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG006
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum
  8. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
    id
    BG007
    title
    Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg
  9. description
    Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG008
    title
    Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.00
          value
          50.0
        2. group Id
          BG001
          spread
          12.41
          value
          62.5
        3. group Id
          BG002
          spread
          13.27
          value
          57.5
        4. group Id
          BG003
          spread
          10.67
          value
          61.6
        5. group Id
          BG004
          spread
          6.38
          value
          64.3
        6. group Id
          BG005
          spread
          6.43
          value
          67.7
        7. group Id
          BG006
          spread
          11.37
          value
          70.3
        8. group Id
          BG007
          spread
          13.82
          value
          56.7
        9. group Id
          BG008
          spread
          12.12
          value
          62.6
        10. group Id
          BG009
          spread
          12.33
          value
          60.7
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          46
        9. group Id
          BG008
          value
          77
        10. group Id
          BG009
          value
          145
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          37
        9. group Id
          BG008
          value
          99
        10. group Id
          BG009
          value
          162
        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
          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
          6
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          77
        9. group Id
          BG008
          value
          159
        10. group Id
          BG009
          value
          283
        title
        Not Hispanic or Latino
      3. 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
          6
        10. group Id
          BG009
          value
          7
        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
        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
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. 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
          3
        10. group Id
          BG009
          value
          3
        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
          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
        10. group Id
          BG009
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          76
        9. group Id
          BG008
          value
          160
        10. group Id
          BG009
          value
          282
        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
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. 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
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, nivolumab, or an applicable chemotherapy regimen.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      13
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      83
    9. group Id
      BG008
      value
      176
    10. group Id
      BG009
      value
      307
    units
    Participants
groups
  1. description
    Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG000
    title
    Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
  2. description
    Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG001
    title
    Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
  3. description
    Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG002
    title
    Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
  4. description
    Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG003
    title
    Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
  5. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG004
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum
  6. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG005
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum
  7. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
    id
    BG006
    title
    Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum
  8. description
    Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
    id
    BG007
    title
    Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg
  9. description
    Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    BG008
    title
    Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.00
          value
          50.0
        2. group Id
          BG001
          spread
          12.41
          value
          62.5
        3. group Id
          BG002
          spread
          13.27
          value
          57.5
        4. group Id
          BG003
          spread
          10.67
          value
          61.6
        5. group Id
          BG004
          spread
          6.38
          value
          64.3
        6. group Id
          BG005
          spread
          6.43
          value
          67.7
        7. group Id
          BG006
          spread
          11.37
          value
          70.3
        8. group Id
          BG007
          spread
          13.82
          value
          56.7
        9. group Id
          BG008
          spread
          12.12
          value
          62.6
        10. group Id
          BG009
          spread
          12.33
          value
          60.7
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          46
        9. group Id
          BG008
          value
          77
        10. group Id
          BG009
          value
          145
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          37
        9. group Id
          BG008
          value
          99
        10. group Id
          BG009
          value
          162
        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
          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
          6
        9. group Id
          BG008
          value
          11
        10. group Id
          BG009
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          77
        9. group Id
          BG008
          value
          159
        10. group Id
          BG009
          value
          283
        title
        Not Hispanic or Latino
      3. 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
          6
        10. group Id
          BG009
          value
          7
        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
        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
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. 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
          3
        10. group Id
          BG009
          value
          3
        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
          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
        10. group Id
          BG009
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          76
        9. group Id
          BG008
          value
          160
        10. group Id
          BG009
          value
          282
        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
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. 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
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          14
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, nivolumab, or an applicable chemotherapy regimen.

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Preserved source evidence · Not medical advice