Participant flow

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) · Source last updated 2026-01-09

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

groups

1. description

   Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

   id

   FG000

   title

   Enfortumab Vedotin 1.25mg/kg

2. description

   Participants received either 75 milligram per square meter (mg/m\^2) docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

   id

   FG001

   title

   Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         46

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         177

      2. group Id

         FG001

         num Subjects

         180

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         27

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         22

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      type

      Miscellaneous

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         301

      2. group Id

         FG001

         num Subjects

         307

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         296

      2. group Id

         FG001

         num Subjects

         291

      type

      Treated

   3. achievements

      1. comment

         Participants still on treatment as of data cut-off date 15-Jul-2020

         group Id

         FG000

         num Subjects

         56

      2. comment

         Participants still on treatment as of data cut-off date 15-Jul-2020

         group Id

         FG001

         num Subjects

         22

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         245

      2. group Id

         FG001

         num Subjects

         285

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were stratified by Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs 1), regions of the world Western EU vs US vs Rest of World) and liver metastasis (Yes vs No).

recruitment Details

Adult participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and had experienced disease progression or relapse during or following treatment with programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.

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Preserved source evidence · Not medical advice