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NCT04995419 · FLOW

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A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy · Source last updated 2025-10-07

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 1.25 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who met inclusion criteria and none of the exclusion criteria were enrolled.
recruitment Details
Adult Chinese participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
Complete source fields
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 1.25 mg/kg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants who met inclusion criteria and none of the exclusion criteria were enrolled.
recruitment Details
Adult Chinese participants with locally advanced or metastatic urothelial cancer (mUC) who had received a platinum-containing chemotherapy and programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.

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

Preserved source evidence · Not medical advice