Study Details

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

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03219333

Astellas Study ID

The unique identification code given by the study sponsor.

SGN22E-001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Bladder Cancer, Kidney Cancer

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Female & Male

Product

enfortumab vedotin

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Oct 2017 - May 2025

Masking

None (Open Label)

Enrollment number

219

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

Study summary

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Locations

James Cancer Hospital / Ohio State University

Columbus, United States, 43210

Site KR82005

Daejeon, Republic of Korea

Site DE49004

Muenster, Germany

New York University (NYU) Cancer Institute

New York, United States, 10016

Site JP81011

Fukuoka, Japan

Site JP81005

Chiba, Japan

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, United States, 14642

Vanderbilt University Medical Center

Nashville, United States, 37204

Massachusetts General Hospital

Boston, United States, 02114

Kaiser Permanente San Leandro

San Leandro, United States, 94577

Site JP81002

Morioka, Japan

H. Lee Moffitt Cancer Center & Research Institute

Tampa, United States, 33612

Thomas Jefferson University

Philadelphia, United States, 19107

Arizona Oncology Associates, PC - HOPE

Tucson, United States, 85710

Augusta University

Augusta, United States, 30912

Site JP81010

Tokushima, Japan

Site JP81006

Shinjuku-ku, Japan

Yale Cancer Center

New Haven, United States, 06520

Arizona Oncology Associates, PC - HAL

Goodyear, United States, 85395

Site JP81007

Osaka, Japan

University of California Irvine - Newport

Orange, United States, 92868

Site NL31001

Amsterdam, Netherlands

Site DE49001

Tübingen, Germany

Kaiser Permanente Sacramento

Sacramento, United States, 95825

Site ES34004

Sevilla, Spain

Site FR33001

Villejuif-Cedex-France, France

Site ES34002

Barcelona, Spain

Keck Medical Center / Newport Beach

Newport Beach, United States, 92663

Mount Sinai Medical Center

New York, United States, 10029

Texas Oncology - Baylor Sammons Cancer Center

Dallas, United States, 75246

Kaiser Permanente Walnut Creek

Walnut Creek, United States, 94596

Site JP81009

Ube, Japan

Keck Medical Center / University of Southern California

Los Angeles, United States, 90033

Site JP81012

Fukuoka, Japan

Site JP81003

Nigata, Japan

Chao Family Comprehensive Cancer Center University of California Irvine

Orange, United States, 92868

Kaiser Permanente San Jose

San Jose, United States, 95119

Site ES34003

Santander, Spain

Alaska Urological Institute

Anchorage, United States, 99503

Kaiser Permanente Oakland

Oakland, United States, 94611

Kaiser Permanente San Francisco

San Francisco, United States, 94115

Site JP81004

Tsukuba, Japan

Texas Oncology - Austin Central

Austin, United States, 78731

Duke University Medical Center

Durham, United States, 27710

Seattle Cancer Care Alliance / University of Washington

Seattle, United States, 98109-1023

Comprehensive Cancer Centers of Nevada

Las Vegas, United States, 89169

Kaiser Permanente Roseville

Roseville, United States, 95661

Karmanos Cancer Institute / Wayne State University

Detroit, United States, 48201

Site IT39001

Milano, Italy

Site KR82001

Seoul, Republic of Korea

Kaiser Permanente Medical Center Northern California

Vallejo, United States, 94589

Site IT39003

Terni, Italy

Kaiser Permanente Santa Clara

Santa Clara, United States, 95051

Virginia Cancer Specialists, PC

Fairfax, United States, 22031

Site JP81001

Hirosaki, Japan

Houston Methodist Cancer Center

Houston, United States, 77030

Kaiser Permanente South San Francisco

South San Francisco, United States, 94080

Site KR82004

Seoul, Republic of Korea

Cleveland Clinic

Cleveland, United States, 44195

Rocky Mountain Cancer Centers - Aurora

Aurora, United States, 80012

Site KR82002

Seoul, Republic of Korea

Virginia Oncology Associates

Norfolk, United States, 23502

Dana Farber Cancer Institute

Boston, United States, 02215

Site KR82003

Seongnam-si, Republic of Korea

Site JP81008

Osakasayama, Japan

Site ES34005

Barcelona, Spain

Mayo Clinic Arizona

Phoenix, United States, 85054

University of Chicago Medical Center

Chicago, United States, 60637-1470

Johns Hopkins Medical Center

Baltimore, United States, 21231

University of Virginia

Charlottesville, United States, 22903

Washington University in St Louis

St. Louis, United States, 63110

University of California Davis

Sacramento, United States, 95817

Memorial Sloan Kettering Cancer Center

New York, United States, 10065

Maryland Oncology Hematology, P.A.

Rockville, United States, 20850

Ocala Oncology Center

Ocala, United States, 34474

Northwest Cancer Specialists, P.C.

Tigard, United States, 97223

New York Oncology Hematology, P.C.

Albany, United States, 12208

Columbia University Medical Center

New York, United States, 10032

University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

Pittsburgh, United States, 15232

Prisma Health

Greenville, United States, 29615

Norton Cancer Institute, St. Matthews Campus

Louisville, United States, 40207