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Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Sponsor: Astellas Pharma Global Development, Inc.
Summary
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Official title: An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
886
Start Date
2020-03-30
Completion Date
2028-03-01
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
Pembrolizumab
IV infusion on Day 1 of every 3-week cycle
Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle
Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
Gemcitabine
IV infusion on Days 1 and 8 of every 3 week cycle
Locations (260)
Ironwood Cancer & Research Centers - Chandler
Chandler, Arizona, United States
Arizona Oncology Associates PD - HOPE
Tucson, Arizona, United States
Providence St Joseph Medical Center
Burbank, California, United States
City of Hope National Medical Center
Duarte, California, United States
University of California Los Angeles Medical Center
Los Angeles, California, United States
University of California Irvine - Newport
Orange, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
University of Colorado Hospital / University of Colorado
Aurora, Colorado, United States
Cancer Centers of Colorado - Denver
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States
Lombardi Cancer Center / Georgetown University Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Marietta, Georgia, United States
Louisiana State University/ East Jefferson General Hospital
Metairie, Louisiana, United States
Maine Health Cancer Care
Biddeford, Maine, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
New York University (NYU) Cancer Institute
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vidant Medical Center
Greenville, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Hillman Cancer Center / University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina, United States
West Cancer Center & Research Institute
Germantown, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
UT Health East Texas Hope Cancer Center
Tyler, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Site AR54008
Buenos Aire, Argentina
Site AR54011
CABA, Argentina
Site AR54005
Córdoba, Argentina
Site AR54006
La Rioja, Argentina
Site AR54004
Mendoza, Argentina
Site AR54001
Rosario, Argentina
Site AR54002
San Miguel, Argentina
Site AR54012
San Miguel de Tucumán, Argentina
Site AR54003
Viedma, Argentina
Site AU61003
Box Hill, Australia
Site AUS61001
Douglas, Australia
Site AUS61004
Heidelberg, Australia
Site AUS61002
Macquarie Park, Australia
Site AUS61006
South Australia, Australia
Site AU61005
South Brisbane, Australia
Site BE32003
Brussels, Belgium
Site BE32002
Ghent, Belgium
Site BE32001
Liège, Belgium
Site BE32007
Lueven, Belgium
Site BE32006
Roeselare, Belgium
Site CA11004
Calgary, Alberta, Canada
Site CA11003
Edmonton, Alberta, Canada
Site CA11006
Vancouver, British Columbia, Canada
Site CA11002
Hamilton, Ontario, Canada
Site CA11009
London, Ontario, Canada
Site CA11011
Oshawa, Ontario, Canada
Site CA11012
Toronto, Ontario, Canada
Site CA11005
Toronto, Ontario, Canada
Site CA11010
Montreal, Quebec, Canada
Site CA11001
Montreal, Quebec, Canada
Site CA11008
Québec, Canada
Site CN86009
Beijing, China
Site CN86001
Beijing, China
Site CN86004
Beijing, China
Site CN86005
Beijing, China
Site CN86015
Bengbu, China
Site CN86003
Changchun, China
Site CN86006
Changsha, China
Site CN86016
Changsha, China
Site CN86010
Chengdu, China
Site CN86024
Chongqing, China
Site CN86007
Chongqing, China
Site CN86028
Fuzhou, China
Site CN86002
Guangzhou, China
Site CN86020
Gunagzhou, China
Site CN86018
Hangzhou, China
Site CN86013
Hangzhou, China
Site CN86022
Hangzhou, China
Site CN86025
Hefei, China
Site CN86027
Jinan, China
Site CN86017
Nanjing, China
Site CN86012
Nanjing, China
Site CN86021
Ningbo, China
Site CN86014
Shanghai, China
Site CN86011
Shenyang, China
Site CN86023
Tianjin, China
Site CN86019
Tianjin, China
Site CN86029
Wenzhou, China
Site CN86008
Wuhan, China
Site CN86030
Xicheng District, China
Site CN86026
Xuzhou, China
Site CZ42006
Brno, Czechia
Site CZ42001
Hradec Králové, Czechia
Site CZ42004
Olomouc, Czechia
Site CZ42005
Praha 4-Krc, Czechia
Site DK45001
Aalborg, Denmark
Site DK45003
Aarhus N, Denmark
Site FR33014
Bordeaux, France
Site FR33016
Lyon, France
Site FR33003
Nice, France
Site FR33020
Pierre-Bénite, France
Site FR33013
Strasbourg, France
Site FR33017
Tours, France
Site FR33011
Villejuif-Cedex-France, France
Site DE49003
Berlin, Germany
Site DE49013
Bielefeld, Germany
Site DE49016
Düsseldorf, Germany
Site DE49014
Erlangen, Germany
Site DE49011
Essen, Germany
Site DE49007
Frankfurt am Main, Germany
Site DE49015
Göttingen, Germany
Site DE49005
Heidelberg, Germany
Site DE49009
Herne, Germany
Site DE49006
Jena, Germany
Site DE49001
Lübeck, Germany
Site DE49008
Magdeburg, Germany
Site DE49012
Mannheim, Germany
Site DE49002
München, Germany
Site DE49004
Tübingen, Germany
Site DE49010
Ulm, Germany
Site HU36003
Budapest, Hungary
Site HU36002
Budapest, Hungary
Site HU36006
Debrecen, Hungary
Site HU36001
Nyíregyháza, Hungary
Site HU36005
Szolnok, Hungary
Site IL97203
Beersheba, Israel
Site IL97201
Haifa, Israel
Site IL97209
Holon, Israel
Site IL97206
Jerusalem, Israel
Site IL97202
Kfar Saba, Israel
Site IL97208
Petah Tikva, Israel
Site IL97211
Rehovot, Israel
Site IL97210
Tel Aviv, Israel
Site IL97204
Tel Litwinsky, Israel
Site IL97205
Ẕerifin, Israel
Site IT39005
Areezo, Italy
Site IT39008
Candiolo, Italy
Site IT39009
Cremona, Italy
Site IT39006
Genova, Italy
Site IT39003
Meldola, Italy
Site IT39014
Milan, Italy
Site IT39007
Milan, Italy
Site IT39004
Pisa, Italy
Site IT39002
Terni, Italy
Site IT39011
Torrette, Italy
Site IT39001
Verona, Italy
Site JP81002
Bunkyō City, Japan
Site JP81009
Chiba, Japan
Site JP81018
Chiba, Japan
Site JP81013
Fukuoka, Japan
Site JP81020
Fukuoka, Japan
Site JP81011
Hirosaki, Japan
Site JP81006
Kawasaki-shi, Japan
Site JP81001
Kōtoku, Japan
Site JP81017
Kyoto, Japan
Site JP81015
Niigata, Japan
Site JP81005
Okayama, Japan
Site JP81008
Osaka, Japan
Site JP81016
Osakasayama-Shi, Japan
Site JP81007
Sapporo, Japan
Site JP81012
Sendai, Japan
Site JP81014
Tokushima, Japan
Site JP81019
Tokyo, Japan
Site JP81003
Toyama, Japan
Site JP81004
Tsukuba, Japan
Site JP81010
Ube, Japan
Site NL31002
Amsterdam, Netherlands
Site NL31001
Amsterdam, Netherlands
Site NL31005
Amsterdam, Noord-Holland, Netherlands
Site NL31007
Leeuwarden, Netherlands
Site NL31004
Nieuwegein, Netherlands
Site NL31003
Rotterdam, Netherlands
Site NL31006
Utrecht, Netherlands
Site PL48002
Warsaw, Poland
Site RU70016
Arkhangelsk, Russia
Site RU70013
Barnaul, Russia
Site RU70020
Ivanovo, Russia
Site RU70014
Krasnoyarsk, Russia
Site RU70006
Leningradskaya Oblast', Russia
Site RU70004
Moscow, Russia
Site RU70011
Moscow, Russia
Site RU70003
Moscow, Russia
Site RU70017
Nizhny Novgorod, Russia
Site RU70002
Omsk, Russia
Site RU70019
Pyatigorsk, Russia
Site RU70010
Saint Petersburg, Russia
Site RU70007
Saint Petersburg, Russia
Site RU70008
Saint Petersburg, Russia
Site RU70012
Saint Petersburg, Russia
Site RU70009
Saransk, Russia
Site RU70015
Tyumen, Russia
Site RU70005
Ufa, Russia
Site SG65001
Singapore, Singapore
Site SG65002
Singapore, Singapore
Site SG65003
Singapore, Singapore
Site KR82001
Daejeon, South Korea
Site KR82002
Goyang-si, South Korea
Site KR82008
Hwasun, South Korea
Site KR82004
Seongnam-si, South Korea
Site KR82003
Seoul, South Korea
Site KR82005
Seoul, South Korea
Site KR82007
Seoul, South Korea
Site KR82006
Seoul, South Korea
Site ES34017
Barcelona, Spain
Site ES34010
Barcelona, Spain
Site ES34006
Barcelona, Spain
Site ES34001
Barcelona, Spain
Site ES34008
Barcelona, Spain
Site ES34013
Córdoba, Spain
Site ES34021
Lugo, Spain
Site ES34018
Madrid, Spain
Site ES34002
Madrid, Spain
Site ES34003
Madrid, Spain
Site ES34015
Madrid, Spain
Site ES34004
Manresa, Spain
Site ES34020
Pamplona, Spain
Site ES34016
Sabadell, Spain
Site ES34012
Santander, Spain
Site ES34007
Seville, Spain
Site ES34019
Valencia, Spain
Site ES34009
Valencia, Spain
Site CH41004
Basel, Switzerland
Site CH41002
Bern, Switzerland
Site CH41001
Chur, Switzerland
Site CH41003
Winterthur, Switzerland
Site TW88603
Kaohsiung City, Taiwan
Site TW88602
Kweishan, Taiwan
Site TW88607
Taichung, Taiwan
Site TW88606
Taichung, Taiwan
Site TW88604
Tainan, Taiwan
Site TW88605
Taipei, Taiwan
Site TW88601
Taipei, Taiwan
Site TH66004
Bangkok, Thailand
Site TH66003
Bangkok, Thailand
Site TH66006
Bangkok, Thailand
Site TH66005
Chiang Mai, Thailand
Site TH66002
Hat Yai, Thailand
Site TH66007
Muang, Thailand
Site TH66001
Ratchathewi, Thailand
Site TR90007
Ankara, Turkey (Türkiye)
Site TR90009
Ankara, Turkey (Türkiye)
Site TR90005
Antalya, Turkey (Türkiye)
Site TR90004
Edirne, Turkey (Türkiye)
Site TR90008
Istanbul, Turkey (Türkiye)
Site TR90003
Istanbul, Turkey (Türkiye)
Site TR90002
Istanbul, Turkey (Türkiye)
Site TR90001
Konya, Turkey (Türkiye)
Site TR90006
Malatya, Turkey (Türkiye)
Site UK44005
Glasgow, United Kingdom
Site UK44001
London, United Kingdom
Site UK44009
London, United Kingdom
Site UK44006
Oxford, United Kingdom
Site UK44010
Plymouth, United Kingdom
Site UK44002
Preston, United Kingdom
Site UK44003
Sheffield, United Kingdom
Site UK44008
Southampton, United Kingdom