Last updated on July 2019

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


Brief description of study

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.

Detailed Study Description

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-nave and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-nave. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.

Clinical Study Identifier: NCT03219333

Find a site near you

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Mayo Clinic Arizona

Scottsdale, AZ United States
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Keck Medical Center / Newport Beach

Newport Beach, CA United States
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Kaiser Permanente Oakland

Oakland, CA United States
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Kaiser Permanente Roseville

Roseville, CA United States
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Kaiser Permanente Sacramento

Sacramento, CA United States
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Kaiser Permanente San Francisco

San Francisco, CA United States
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Kaiser Permanente San Jose

San Jose, CA United States
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Kaiser Permanente San Leandro

San Leandro, CA United States
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Kaiser Permanente Santa Clara

Santa Clara, CA United States
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Kaiser Permanente South San Francisco

South San Francisco, CA United States
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Kaiser Permanente Walnut Creek

Walnut Creek, CA United States
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Yale Cancer Center

New Haven, CT United States
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Ocala Oncology Center

Ocala, FL United States
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Augusta University

Augusta, GA United States
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University of Chicago

Chicago, IL United States
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Norton Cancer Institute

Louisville, KY United States
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Johns Hopkins Medical Center

Baltimore, MD United States
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Maryland Oncology Hematology, P.A.

Silver Spring, MD United States
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Mount Sinai Medical Center

New York, NY United States
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Cleveland Clinic, The

Cleveland, OH United States
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Thomas Jefferson University

Philadelphia, PA United States
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University of Virginia

Charlottesville, VA United States
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Site FR33001

Villejuif-Cedex-France, France
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Site DE49004

Muenster, Germany
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Site DE49001

Tübingen, Germany
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Site JP81001

Hirosaki, Japan
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Site JP81008

Osakasayama, Japan
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Site JP81006

Shinjuku-ku, Japan
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Site JP81010

Tokushima, Japan
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Site KR82005

Daejeon, Korea, Republic of
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Site KR82003

Seongnam-si, Korea, Republic of
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Site KR82001

Seoul, Korea, Republic of
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Site KR82002

Seoul, Korea, Republic of
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Site KR82004

Seoul, Korea, Republic of
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Site NL31001

Amsterdam, Netherlands
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Site ES34002

Barcelona, Spain
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Site ES34003

Santander, Spain
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Site DE49001

Tübingen, Germany
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Alaska Urological Institute

Anchorage, AK United States
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Site DE49001

Tübingen, Germany
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Site DE49001

Tübingen, Germany
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Recruitment Status: Open


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