Participant flow

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) · Source last updated 2026-05-27

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

groups

1. description

   Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

   id

   FG000

   title

   Nivolumab + Ipilimumab

2. description

   Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

   id

   FG001

   title

   Sunitinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant request to discontinue study treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Poor/Non-compliance

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant no longer meet study criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         550

      2. group Id

         FG001

         num Subjects

         546

      comment

      Started = Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         547

      2. group Id

         FG001

         num Subjects

         535

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Pre-treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         269

      2. group Id

         FG001

         num Subjects

         366

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         73

      type

      Study Drug Toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         35

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         22

      type

      Participant Request to Discontinue Study Treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         6

      type

      Maximum Clinical Benefit

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor/Non-compliance

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Pregnancy

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Participant No Longer Meet Study Criteria

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Administration Reason by Sponsor

   Show more (12 of 13)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         547

      2. group Id

         FG001

         num Subjects

         535

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         Participants received Nivolumab combined with Ipilimumab followed by Nivolumab

         group Id

         FG001

         num Subjects

         25

      type

      Crossover Extension Phase (Arm B)

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         547

      2. group Id

         FG001

         num Subjects

         533

      type

      NOT COMPLETED

   title

   Treatment Period

pre Assignment Details

A total of 1096 participants were randomized, with 550 assigned to the Nivolumab + Ipilimumab group and 546 assigned to the Sunitinib group. Of these, 1082 participants received at least one dose of study treatment, including 547 in the Nivolumab + Ipilimumab group and 535 in the Sunitinib group.

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

Preserved source evidence · Not medical advice