Participant flow

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer · Source last updated 2026-05-29

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

groups

1. description

   Participants received enfortumab vedotin at 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.

   id

   FG000

   title

   Enfortumab Vedotin + Pembrolizumab

2. description

   Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (area under curve \[AUC\] 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.

   id

   FG001

   title

   Standard of Care

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         153

      2. group Id

         FG001

         num Subjects

         73

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         97

      2. group Id

         FG001

         num Subjects

         62

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         28

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         24

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         11

      type

      Randomized but not treated

   7. reasons

      1. group Id

         FG000

         num Subjects

         144

      2. group Id

         FG001

         num Subjects

         0

      type

      On-treatment

   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

         440

      2. group Id

         FG001

         num Subjects

         433

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         244

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         434

      2. group Id

         FG001

         num Subjects

         200

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results are reported only for primary outcome measures at primary completion date (08-Aug-2023). Remaining secondary outcome measures whose analysis are not final, results would be reported at study completion date.

recruitment Details

Participants with untreated locally advanced or metastatic urothelial cancer (UC) were enrolled in the study.

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Preserved source evidence · Not medical advice