Participant flow

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) · Source last updated 2026-08-20

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

groups

1. description

   Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.

   id

   FG000

   title

   Arm A - Nivolumab Monotherapy

2. description

   Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.

   id

   FG001

   title

   Arm B - Nivolumab + Ipilimumab

3. description

   Participants received standard of care chemotherapy

   id

   FG002

   title

   Arm C - Investigator's Choice 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

         9

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      type

      Participant no longer meets study criteria

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         6

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         353

      2. group Id

         FG001

         num Subjects

         354

      3. group Id

         FG002

         num Subjects

         132

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         351

      2. group Id

         FG001

         num Subjects

         352

      3. group Id

         FG002

         num Subjects

         115

      comment

      Treated

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Pre-Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Pregnancy

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Participant no longer meets study criteria

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         6

      type

      Other reasons

   6. reasons

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         82

      3. group Id

         FG002

         num Subjects

         85

      type

      Disease Progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         48

      3. group Id

         FG002

         num Subjects

         8

      type

      Study drug toxicity

   8. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         22

      3. group Id

         FG002

         num Subjects

         6

      type

      Adverse Event unrelated to study drug

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         9

      type

      Maximum Clinical Benefit

   10. reasons

       1. group Id

          FG000

          num Subjects

          13

       2. group Id

          FG001

          num Subjects

          20

       3. group Id

          FG002

          num Subjects

          0

       type

       On-going treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         351

      2. group Id

         FG001

         num Subjects

         352

      3. group Id

         FG002

         num Subjects

         115

      comment

      Treated

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         60

      type

      Crossover to Arm B

   3. achievements

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         159

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         214

      2. group Id

         FG001

         num Subjects

         193

      3. group Id

         FG002

         num Subjects

         115

      type

      NOT COMPLETED

   title

   Treatment

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice