Participant flow

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) · Source last updated 2022-09-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

   id

   FG000

   title

   Group A: Epa + Pembrolizumab +mFOLFOX6

2. description

   Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

   id

   FG001

   title

   Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine

3. description

   Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

   id

   FG002

   title

   Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin

4. description

   Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

   id

   FG003

   title

   Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent

5. description

   Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

   id

   FG004

   title

   Group E: Epa + Pembrolizumab + Cyclophosphamide

6. description

   Epa (100mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

   id

   FG005

   title

   Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent

7. description

   Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

   id

   FG006

   title

   Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         2

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      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

         1

      7. group Id

         FG006

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         6

      type

      Reason was not specified,

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      type

      Progressive Disease

   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

         2

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      type

      Study Terminated by the Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         13

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         11

      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

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         13

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 25 Oct 2018 as a strategic decision. At the time of data cut-off date of 25 Jan 2019, 11 participants were ongoing on treatment. . Phase 2 consisted of efficacy expansion and Mandatory biopsy cohorts. Phase 2 Efficacy expansion cohorts did not open for enrollment. Phase 2/Mandatory biopsy cohorts opened for enrollment and only groups C, D and E enrolled participants prior to study termination

recruitment Details

The study was conducted at 9 study sites in the US. Phases 1 and 2 each consisted of Treatment Groups A-G, and every patient in the same group in Phases 1 and 2 received the same dose of epacadostat (100 mg BID oral), pembrolizumab (200 mg IV), and the respective chemotherapy regimens. Data analysis and summarization were performed by treatment group, by combining data of the same group in Phases 1 and 2.

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Preserved source evidence · Not medical advice