Participant flow

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin · Source last updated 2026-02-17

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

groups

1. description

   Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.

   id

   FG000

   title

   Arm A: Nivolumab + Ipilimumab

2. description

   Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

   id

   FG001

   title

   Arm B: Nivolumab + Chemotherapy

3. description

   Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

   id

   FG002

   title

   Arm C: Chemotherapy

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

         2

      type

      Participant request to discontinue study treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         12

      type

      Participant withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      type

      Participant no longer meets study criteria

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      Other Reasons

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      type

      Disease Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      type

      Adverse event unrelated to study drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         325

      2. group Id

         FG001

         num Subjects

         321

      3. group Id

         FG002

         num Subjects

         324

      comment

      Started=Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         322

      2. group Id

         FG001

         num Subjects

         310

      3. group Id

         FG002

         num Subjects

         304

      comment

      Completed=Treated

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         20

      type

      NOT COMPLETED

   title

   Pre-Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         191

      3. group Id

         FG002

         num Subjects

         199

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         36

      3. group Id

         FG002

         num Subjects

         38

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         26

      3. group Id

         FG002

         num Subjects

         11

      type

      Adverse event unrelated to study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         22

      3. group Id

         FG002

         num Subjects

         21

      type

      Participant request to discontinue study treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         12

      type

      Participant withdrew consent

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Pregnancy

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      type

      Maximum clinical benefit

   9. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         0

      type

      Completed treatment as per Protocol

   10. reasons

       1. group Id

          FG000

          num Subjects

          10

       2. group Id

          FG001

          num Subjects

          10

       3. group Id

          FG002

          num Subjects

          15

       type

       Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         322

      2. group Id

         FG001

         num Subjects

         310

      3. group Id

         FG002

         num Subjects

         304

      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

      comment

      Completed=continuing treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         322

      2. group Id

         FG001

         num Subjects

         310

      3. group Id

         FG002

         num Subjects

         304

      type

      NOT COMPLETED

   title

   Treatment

pre Assignment Details

970 participants randomized, 936 treated.

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Preserved source evidence · Not medical advice