Participant flow

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.

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

   FG000

   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

   FG001

   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

   FG002

   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

   FG003

   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

   FG004

   title

   Phase 2: Epacadostat 100 mg BID

periods

1. drop Withdraws

   1. 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

         2

      5. group Id

         FG004

         num Subjects

         33

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         12

      5. group Id

         FG004

         num Subjects

         205

      type

      Death

   3. 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

         2

      5. group Id

         FG004

         num Subjects

         11

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         128

      type

      Study 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

         0

      5. group Id

         FG004

         num Subjects

         3

      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

         0

      5. group Id

         FG004

         num Subjects

         2

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         20

      5. group Id

         FG004

         num Subjects

         382

      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

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         18

      4. group Id

         FG003

         num Subjects

         20

      5. group Id

         FG004

         num Subjects

         382

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Prior to 17May18 study amended/discontinued, 444 participants were enrolled. Survival follow up and monotherapy option after discontinuation of combination were removed so anyone in survival follow up were discontinued the study and were assigned to "study terminated by sponsor" because completed was not an option in the database for those in survival follow up. 1 patient on combo treatment did not move to the monotherapy so they were also assigned to this reason for discontinuing.

recruitment Details

Participants took part in the study at 22 investigative sites in the United States from 17July 2014 to 06 November 2020.

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

Preserved source evidence · Not medical advice