Study Details

A Study to Evaluate Enfortumab Vedotin versus (vs) Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

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. ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

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



Bladder Cancer


These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3


18 Years - N/A


Female & Male


enfortumab vedotin


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.


Trial Dates

Jun 2018 - Feb 2024


None (Open Label)

Enrollment number


An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Study summary

Get More Information

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Site AT43005

Linz, Austria

Innovative Clinical Research

Whittier, United States, 90606

Site JP81023

Fukuoka, Japan

Fox Chase Cancer Center

Philadelphia, United States, 19111

Site JP81001

Kyoto, Japan

Site NL31001

Tilburg, Netherlands

HOPE Cancer Center of East Texas

Tyler, United States, 75701

Site AU61002

Sydney, Australia

Montefiore Medical Center

Bronx, United States, 10467

Site DK45003

Aalborg, Denmark

Site ES34005

Seville, Spain

Site CA15013

Vancouver, Canada

University of California

Sacramento, United States, 95817

Providence Portland Med Center

Portland, United States, 97213

Site RU70005

Omsk, Russian Federation

Site JP81004

Hiroshima, Japan

Site DE49008

Heidelberg, Germany

Site ES34008

Valencia, Spain

Site ES34002

Badalona, Spain

Site CA15015

Calgary, Canada

Site ES34023

Barcelona, Spain

Site CA15001

Sherbrooke, Canada

Site CH41001

Chur, Switzerland

Site IT39013

Pisa, Italy

Site IT39025

Modena, Italy

Fairview Ridges Specialty Center

Burnsville, United States, 55337

Site FR33022

Paris, France

Site BE32010

Charleroi, Belgium

Site JP81013

Shinjuku-ku, Japan

Site JP81012

Koto-ku, Japan

Site JP81011

Ube, Japan

Site GB44011

Southampton, United Kingdom

Site JP81002

Yokohama, Japan

Site JP81014

Kashiwa, Japan

Site ES34019

Pamplona, Spain

Site GB44004

Wirral, United Kingdom

Site BE32011

Aalst, Belgium

Allina Health System

Minneapolis, United States, 55407

Site ES34003

Madrid, Spain

Medical College of Wisconsin

Milwaukee, United States, 53226

Site ES34017

Madrid, Spain

Site NL31003

Amsterdam, Netherlands

Site KR82012

Hwasun-gun, Republic of Korea

Site PT35105

Lisboa, Portugal

Site KR82001

Seongnam-si, Republic of Korea

Site GB44005

London, United Kingdom

Site FR33001

Brest, France

Site FR33014

Marseille, France

Site CA15014

London, Canada

UCI Chao Family Comprehensive Cancer Center

Orange, United States, 92868

Site BE32002

Roeselare, Belgium

Site GB44002

Sheffield, United Kingdom

Site JP81016

Osakasayama, Japan

Site ES34006

Madrid, Spain

Site IT39023

Lucca, Italy

Site ES34014

Córdoba, Spain

Site FR33009

Bordeaux, France

Site CA15007

Montreal, Canada

Site IT39018

Turin, Italy

Site NL31002

Amsterdam, Netherlands

Site IT39026

Moldova, Italy

Site JP81018

Morioka, Japan

Site JP81007

Sapporo, Japan

Site BE32003

Leuven, Belgium

Site FR33020

Montpellier, France

Site TW88607

Taoyuan, Taiwan, Province of China

Site JP81026

Sapporo, Japan

Site AU61001

Miranda, Australia

Site ES34012

Barcelona, Spain

Site JP81010

Hirosaki, Japan

Site DE49003

Tübingen, Germany

Toledo Clinic Cancer Center

Toledo, United States, 43623

Site IT39019

Cremona, Italy

Sidney Kimmel Center for Prostate and Urologic Cancers

New York City, United States, 10065

Site IT39014

Reggio Emilia, Italy

Site JP81005

Sendai, Japan

Site GB44008

Manchester, United Kingdom

Site PT35106

Porto, Portugal

Site AR54001

Buenos Aires, Argentina

University of Colorado

Denver, United States, 80045

Site CA15017

Kelowna, Canada

Site KR82004

Seoul, Republic of Korea

Site FR33004

Saint-Mande, France

Site ES34024

Santander, Spain

Dayton Physicians LLC

Dayton, United States, 45430

Medical Oncology Associates, PS

Spokane, United States, 99208

Site JP81008

Bunkyo-ku, Japan

Site TW88605

Kaohsiung, Taiwan, Province of China

Site GB44013

Sutton, United Kingdom

Smilow Cancer Hospital at Yale-New Haven

New Haven, United States, 06510

Providence St. Mary Regional Center

Lacey, United States, 98503

Site CA15008

Saskatoon, Canada

Site ES34011

Manresa, Spain

Site IT39010

Milan, Italy

Site RU70009

Obninsk, Russian Federation

Site AU61006

Adelaide, Australia

Roswell Park Cancer Institute

Buffalo, United States, 14263

University of Pennsylvania

Philadelphia, United States, 19104

Site CA15011

Oshawa, Canada

Site KR82003

Seoul, Republic of Korea

Site IT39004

Terni, Italy

Site JP81003

Okayama, Japan

Site JP81017

Niigata, Japan

Site BE32008

Gent, Belgium

Site AT43004

Wien, Austria

Site RU70015

Vologda, Russian Federation

Site FR33019

Toulouse, France

Site FR33021

Besancon, France

Site IT39027

Rome, Italy

Site CH41002

Bern, Switzerland

Site ES34015

Madrid, Spain

Site AU61004

St. Leonards, Australia

Site FR33005

Pierre-Bénite, France

Nebraska Cancer Specialists

Omaha, United States, 68130

Site FR33012

Paris, France

Saint Francis Hospital

Greenville, United States, 29607

Site TW88604

Taipei, Taiwan, Province of China

Site FR33002

Strasbourg, France

Site IT39008

Arezzo, Italy

Lifespan Rhode Island Hospital

Providence, United States, 02903

Site PT35102

Lisbon, Portugal

Site FR33016

Caen, France

Site AR54003

Buenos Aires, Argentina

Alaska Clinical Research Center

Anchorage, United States, 99508

Site BE32001

Gent, Belgium

Site KR82006

Daejeon, Republic of Korea

Site KR82002

Incheon, Republic of Korea

Site DE49009

Würzburg, Germany

Site CA15002

Montreal, Canada

Site BE32012

Yvoir, Belgium

Site JP81022

Osaka, Japan

Site CH41003

Winterthur, Switzerland

Site JP81006

Toyama, Japan

Site AR54002

San Miguel de Tucumán, Argentina

Site FR33015

Lyon, France

Site TW88601

Tainan, Taiwan, Province of China

Site ES34001

Barcelona, Spain

Site CA15003

Hamilton, Canada

Site TW88606

Taichung, Taiwan, Province of China

Site ES34013

Madrid, Spain

The Oncology Institute of Hope

Corona, United States, 92882

Rush University Medical Center

Chicago, United States, 60612

Site JP81021

Tokushima, Japan

Site CA15005

Toronto, Canada

Site KR82010

Seoul, Republic of Korea

Site AT43001

Salzburg, Austria

Norton Cancer Institute

Louisville, United States, 40207

Site ES34022

Santiago de Compostela, Spain

Site IT39006

San Giovanni Rotondo, Italy

Site ES34020

Oviedo, Spain

Site BE32013

Brussels, Belgium

Site FR33003

Nice, France

Site AU61003

Douglas, Australia

White Plains Hospital Center for Cancer Care – Oncology Site

White Plains, United States, 10601

Site DK45001

Herlev, Denmark

Site ES34010

Badajoz, Spain

Queens Medical Associates

Fresh Meadows, United States, 11366-1531

Site DE49010

Münster, Germany

Site ES34007

Valencia, Spain

Site KR82008

Seoul, Republic of Korea

Site TW88602

Kaohsiung, Taiwan, Province of China

UMass Memorial Medical Center

Worcester, United States, 01605

Site RU70002

Ivanovo, Russian Federation

Piedmont Cancer Institute

Atlanta, United States, 30318

Site GB44006

London, United Kingdom

W.G. Hefner VA Medical Center

Salisbury, United States, 28144

Site JP81015

Chiba, Japan

Site NL31009

Nijmegen, Netherlands

Site FR33006

Villejuif, France

Sylvester Comprehensive Cancer Center

Miami, United States, 33136

Dana-Farber Cancer Institute

Boston, United States, 02215

Benaroya Research Institute at Virginia Mason

Seattle, United States, 98101

Site JP81024

Takatsuki, Japan

Florida Hospital

Orlando, United States, 32804

Site CA15004

Quebec, Canada

Site BE32005

Hasselt, Belgium

Site JP81009

Kita-gun, Japan

Site DK45004

Copenhagen, Denmark

Site KR82005

Shin, Republic of Korea

Site DE49011

Essen, Germany

Site JP81019

Fukuoka, Japan

Ochsner Clinic Foundation

New Orleans, United States, 70121

Site BE32007

Brussels, Belgium

Site FR33018

Bordeaux, France

Site BE32009

Liège, Belgium

Site KR82007

Goyang-Si, Republic of Korea

Site CA15012

Edmonton, Canada

Site KR82009

Seoul, Republic of Korea

Site DE49013

Dresden, Germany

Long Island Jewish Medical Center

Lake Success, United States, 11042

Site JP81020

Tsukuba, Japan