Participant flow

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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

groups

1. description

   Participants with advanced renal cell carcinoma (aRCC) received avelumab 10 milligram per kilogram (mg/kg), intravenously (IV) once every two weeks (Q2W) in a 6-week cycle plus axitinib 5 mg, orally twice daily (BID). Each treatment cycle was of 42 days.

   id

   FG000

   title

   Avelumab + Axitinib

2. description

   Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.

   id

   FG001

   title

   Sunitinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         6

      type

      Other

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-compliance with study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      type

      No longer met eligibility criteria

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         22

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      type

      Global deterioration of health status

   8. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         8

      type

      Physician Decision

   9. reasons

      1. group Id

         FG000

         num Subjects

         86

      2. group Id

         FG001

         num Subjects

         65

      type

      Adverse Event

   10. reasons

       1. group Id

          FG000

          num Subjects

          29

       2. group Id

          FG001

          num Subjects

          43

       type

       Withdrawal by Subject

   11. reasons

       1. group Id

          FG000

          num Subjects

          236

       2. group Id

          FG001

          num Subjects

          266

       type

       Progressive disease

   12. reasons

       1. group Id

          FG000

          num Subjects

          6

       2. group Id

          FG001

          num Subjects

          9

       type

       Participation terminated by sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         442

      2. group Id

         FG001

         num Subjects

         444

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         442

      2. group Id

         FG001

         num Subjects

         444

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 886 participants were enrolled and randomized in the study.

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

Preserved source evidence · Not medical advice