Spots Global Cancer Trial Database for Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
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Trial Identification
Brief Title: Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
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
Study ID: NCT04223856
Conditions
Study Description
Brief 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.
Detailed Description: Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan. This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer. Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Cordoba, , Argentina
Site AR54006, La Rioja, , Argentina
Site AR54004, Mendoza, , Argentina
Site AR54001, Rosario, , Argentina
Site AR54002, San Miguel, , Argentina
Site AR54012, Tucuman, , 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, Liege, , 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, Quebec, , Canada
Site CN86009, Beijing City, , 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 City, , China
Site CN86023, Tianjin, , China
Site CN86019, Tianjin, , China
Site CN86029, Wenzhou, , China
Site CN86008, Wuhan City, , China
Site CN86030, Xicheng District, , China
Site CN86026, Xuzhou, , China
Site CZ42006, Brno, , Czechia
Site CZ42001, Hradec Kralove, , 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 Cedex 2, , France
Site FR33020, Pierre-Bénite, , France
Site FR33013, Strasbourg, , France
Site FR33017, TOURS Cedex 09, , 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, Gottingen, , Germany
Site DE49005, Heidelberg, , Germany
Site DE49009, Herne, , Germany
Site DE49006, Jena, , Germany
Site DE49001, Lubeck, , Germany
Site DE49008, Magdeburg, , Germany
Site DE49012, Mannheim, , Germany
Site DE49002, Munchen, , Germany
Site DE49004, Tübingen, , Germany
Site DE49010, Ulm, , Germany
Site HU36003, Budapest, , Hungary
Site HU36002, Budapest, , Hungary
Site HU36006, Debrecen, , Hungary
Site HU36001, Nyiregyhaza, , Hungary
Site HU36005, Szolnok, , Hungary
Site IL97203, Beer Sheva, , Israel
Site IL97201, Haifa, , Israel
Site IL97209, Holon, , Israel
Site IL97206, Jerusalem, , Israel
Site IL97202, Kfar Saba, , Israel
Site IL97208, Petach Tikva, , Israel
Site IL97211, Rehovot, , Israel
Site IL97210, Tel Aviv, , Israel
Site IL97204, Tel Hashomer, , Israel
Site IL97205, Zerifin, , Israel
Site IT39005, Areezo, , Italy
Site IT39008, Candiolo, , Italy
Site IT39009, Cremona, , Italy
Site IT39006, Genova, , Italy
Site IT39003, Meldola, , Italy
Site IT39014, Milano, , Italy
Site IT39007, Milano, , Italy
Site IT39004, Pisa, , Italy
Site IT39002, Terni, , Italy
Site IT39011, Torrette, , Italy
Site IT39001, Verona, , Italy
Site JP81002, Bunkyo 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, Koto-ku, , Japan
Site JP81017, Kyoto, , Japan
Site JP81015, Niigata, , Japan
Site JP81005, Okayama, , Japan
Site JP81016, Osakasayama-Shi, , Japan
Site JP81008, Osaka, , Japan
Site JP81007, Sapporo, , Japan
Site JP81012, Sendai-city, , Japan
Site JP81014, Tokushima, , Japan
Site JP81019, Tokyo, , Japan
Site JP81003, Toyama, , Japan
Site JP81004, Tsukuba, , Japan
Site JP81010, Ube, , Japan
Site KR82001, Daejeon, , Korea, Republic of
Site KR82002, Goyang-si, , Korea, Republic of
Site KR82008, Hwasun, , Korea, Republic of
Site KR82004, Seongnam-si, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site NL31005, Amsterdam, Noord-Holland, , Netherlands
Site NL31002, Amsterdam, , Netherlands
Site NL31001, Amsterdam, , Netherlands
Site NL31007, Leeuwarden, , Netherlands
Site NL31004, Nieuwegein, , Netherlands
Site NL31003, Rotterdam, , Netherlands
Site NL31006, Utrecht, , Netherlands
Site PL48002, Warszawa, , Poland
Site RU70016, Arkhangelsk, , Russian Federation
Site RU70013, Barnaul, , Russian Federation
Site RU70020, Ivanovo, , Russian Federation
Site RU70014, Krasnoyarsk, , Russian Federation
Site RU70006, Leningradskaya Oblast', , Russian Federation
Site RU70004, Moscow, , Russian Federation
Site RU70011, Moscow, , Russian Federation
Site RU70003, Moscow, , Russian Federation
Site RU70017, Nizhniy Novgorod, , Russian Federation
Site RU70002, Omsk, , Russian Federation
Site RU70019, Pyatigorsk, , Russian Federation
Site RU70010, Saint Petersburg, , Russian Federation
Site RU70007, Saint Petersburg, , Russian Federation
Site RU70012, Saint-Petersburg, , Russian Federation
Site RU70009, Saransk, , Russian Federation
Site RU70008, St. Petersburg, , Russian Federation
Site RU70015, Tyumen, , Russian Federation
Site RU70005, Ufa, , Russian Federation
Site SG65001, Singapore, , Singapore
Site SG65002, Singapore, , Singapore
Site SG65003, Singapore, , Singapore
Site ES34017, Barcelona, , Spain
Site ES34010, Barcelona, , Spain
Site ES34006, Barcelona, , Spain
Site ES34001, Barcelona, , Spain
Site ES34008, Barcelona, , Spain
Site ES34013, Cordoba, , 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, Sevilla, , 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, , 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 TH66005, Chiang Mai, , Thailand
Site TH66002, HatYai, , Thailand
Site TH66006, Krung Thep Maha Nakhon, , Thailand
Site TH66007, Muang, , Thailand
Site TH66001, Ratchathewi, , Thailand
Site TR90007, Ankara, , Turkey
Site TR90009, Ankara, , Turkey
Site TR90005, Antalya, , Turkey
Site TR90004, Edirne, , Turkey
Site TR90008, Istanbul, , Turkey
Site TR90003, Istanbul, , Turkey
Site TR90002, Istanbul, , Turkey
Site TR90001, Konya, , Turkey
Site TR90006, Malatya, , Turkey
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
Contact Details
Name: Zejing Wang, MD, PhD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
Name: John Lu, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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