Participant flow

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.

groups

1. description

   Participants received epacadostat 25 mg, orally, twice daily (BID) in combination of nivolumab 3 mg/kg intravenously (IV), on Days 1, 15, 29, and 43 of each 8-week cycle.

   id

   FG000

   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, once every 3 weeks (Q3W), on Days 1, 15, 29, and 43 of each 8-week cycle.

   id

   FG001

   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

   FG002

   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

   FG003

   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, once every 2 weeks (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

   FG004

   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

   FG005

   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

   FG006

   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 once every 4 weeks (Q4W) on Days 1 and Day 29 of each 8-week cycle.

   id

   FG007

   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

   FG008

   title

   Phase 2: Epacadostat 300 mg + Nivolumab 240 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         11

      9. group Id

         FG008

         num Subjects

         25

      type

      Participants Decision: Consent Withdrawal from Study and Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         51

      9. group Id

         FG008

         num Subjects

         97

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         5

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         11

      9. group Id

         FG008

         num Subjects

         25

      type

      Site Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         1

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         11

      type

      Completed 100 Day Safety Follow-up Period

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         12

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         83

      9. group Id

         FG008

         num Subjects

         176

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         83

      9. group Id

         FG008

         num Subjects

         176

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 307 participants were enrolled in this study, 48 participants were enrolled in Phase 1 and 259 participants were enrolled in Phase 2. Participants in Phase 1 Part 2 and Phase 2 received dose per select solid tumor types (Colorectal, Melanoma I/O Naïve, Melanoma I/O relapsed, Melanoma I/O refractory, Non-small cell lung cancer (NSCLC), Ovarian, Squamous cell carcinoma of the head and neck (SCCHN), Diffuse large B-cell lymphoma (DLBCL) and Glioblastoma).

recruitment Details

Participants took part in 22 study sites in the United States and 2 study sites in the United Kingdom from 26 November 2014 to 16 June 2020.

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Preserved source evidence · Not medical advice