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Completed Phase 2 Interventional Results available

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

ClinicalTrials.gov ID: NCT03219333

Public ClinicalTrials.gov record NCT03219333. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: * Patients have already received treatment with platinum-containing chemotherapy * Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

Study identification

NCT ID
NCT03219333
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
219 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 8, 2017 (Actual)
Primary completion
Oct 27, 2020 (Actual)
Completion
Jul 28, 2023 (Actual)
Last update posted
Aug 27, 2024

2017 – 2023

United States locations

U.S. sites
54
U.S. states
24
U.S. cities
48
Facility City State ZIP Site status
Alaska Urological Institute Anchorage Alaska 99503 —
Arizona Oncology Associates, PC - HAL Goodyear Arizona 85395 —
Mayo Clinic Arizona Phoenix Arizona 85054 —
Arizona Oncology Associates, PC - HOPE Tucson Arizona 85710 —
Keck Medical Center / University of Southern California Los Angeles California 90033 —
Keck Medical Center / Newport Beach Newport Beach California 92663 —
Kaiser Permanente Oakland Oakland California 94611 —
Chao Family Comprehensive Cancer Center University of California Irvine Orange California 92868 —
University of California Irvine - Newport Orange California 92868 —
Kaiser Permanente Roseville Roseville California 95661 —
University of California Davis Sacramento California 95817 —
Kaiser Permanente Sacramento Sacramento California 95825 —
Kaiser Permanente San Francisco San Francisco California 94115 —
Kaiser Permanente San Jose San Jose California 95119 —
Kaiser Permanente San Leandro San Leandro California 94577 —
Kaiser Permanente Santa Clara Santa Clara California 95051 —
Kaiser Permanente South San Francisco South San Francisco California 94080 —
Kaiser Permanente Medical Center Northern California Vallejo California 94589 —
Kaiser Permanente Walnut Creek Walnut Creek California 94596 —
Rocky Mountain Cancer Centers - Aurora Aurora Colorado 80012 —
Yale Cancer Center New Haven Connecticut 06520 —
Ocala Oncology Center Ocala Florida 34474 —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida 33612 —
Augusta University Augusta Georgia 30912 —
University of Chicago Medical Center Chicago Illinois 60637-1470 —
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky 40207 —
Johns Hopkins Medical Center Baltimore Maryland 21231 —
Maryland Oncology Hematology, P.A. Rockville Maryland 20850 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Karmanos Cancer Institute / Wayne State University Detroit Michigan 48201 —
Washington University in St Louis St Louis Missouri 63110 —
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169 —
New York Oncology Hematology, P.C. Albany New York 12208 —
New York University (NYU) Cancer Institute New York New York 10016 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
James P. Wilmot Cancer Center / University of Rochester Medical Center Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27710 —
Cleveland Clinic Cleveland Ohio 44195 —
James Cancer Hospital / Ohio State University Columbus Ohio 43210 —
Northwest Cancer Specialists, P.C. Tigard Oregon 97223 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Prisma Health Greenville South Carolina 29615 —
Vanderbilt University Medical Center Nashville Tennessee 37204 —
Texas Oncology - Austin Central Austin Texas 78731 —
Texas Oncology - Baylor Sammons Cancer Center Dallas Texas 75246 —
Houston Methodist Cancer Center Houston Texas 77030 —
University of Virginia Charlottesville Virginia 22903 —
Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Seattle Cancer Care Alliance / University of Washington Seattle Washington 98109-1023 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03219333, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2024 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03219333 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →