Spots Global Cancer Trial Database for A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
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Trial Identification
Brief Title: A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Official Title: 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 ID: NCT03474107
Study Description
Brief Summary: The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy. This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy. In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.
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. Participants considered an adult according to local regulation at the time of obtaining informed consent participated in the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCI Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California, Sacramento, California, United States
Innovative Clinical Research, Whittier, California, United States
University of Colorado, Denver, Colorado, United States
Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Florida Hospital, Orlando, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Long Island Jewish Medical Center, Lake Success, New York, United States
Sidney Kimmel Center for Prostate and Urologic Cancers, New York, New York, United States
White Plains Hospital Center for Cancer Care - Oncology Site, White Plains, New York, United States
Toledo Clinic Cancer Center, Toledo, Ohio, United States
Providence Portland Med Center, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Lifespan Rhode Island Hospital, Providence, Rhode Island, United States
Saint Francis Hospital, Greenville, South Carolina, United States
HOPE Cancer Center of East Texas, Tyler, Texas, United States
Benaroya Research Institute at Virginia Mason, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Site AR54001, Buenos Aires, , Argentina
Site AU61006, Adelaide, , Australia
Site AU61001, Miranda, , Australia
Site AU61004, St. Leonards, , Australia
Site AU61002, Sydney, , Australia
Site AT43005, Linz, , Austria
Site AT43001, Salzburg, , Austria
Site AT43004, Wien, , Austria
Site BE32011, Aalst, , Belgium
Site BE32007, Brussels, , Belgium
Site BE32013, Brussels, , Belgium
Site BE32010, Charleroi, , Belgium
Site BE32001, Gent, , Belgium
Site BE32008, Gent, , Belgium
Site BE32005, Hasselt, , Belgium
Site BE32003, Leuven, , Belgium
Site BE32009, Liège, , Belgium
Site CA15015, Calgary, , Canada
Site CA15012, Edmonton, , Canada
Site CA15014, London, , Canada
Site CA15002, Montreal, , Canada
Site CA15007, Montreal, , Canada
Site CA15011, Oshawa, , Canada
Site CA15004, Quebec, , Canada
Site CA15008, Saskatoon, , Canada
Site CA15001, Sherbrooke, , Canada
Site CA15005, Toronto, , Canada
Site CA15013, Vancouver, , Canada
Site DK45003, Aalborg, , Denmark
Site DK45004, Copenhagen, , Denmark
Site DK45001, Herlev, , Denmark
Site FR33021, Besancon, , France
Site FR33009, Bordeaux, , France
Site FR33018, Bordeaux, , France
Site FR33001, Brest, , France
Site FR33016, Caen, , France
Site FR33015, Lyon, , France
Site FR33014, Marseille, , France
Site FR33003, Nice, , France
Site FR33022, Paris, , France
Site FR33005, Pierre-Bénite, , France
Site FR33004, Saint-Mande, , France
Site FR33002, Strasbourg, , France
Site FR33019, Toulouse, , France
Site FR33006, Villejuif, , France
Site DE49011, Essen, , Germany
Site DE49008, Heidelberg, , Germany
Site DE49010, Münster, , Germany
Site DE49003, Tübingen, , Germany
Site DE49009, Würzburg, , Germany
Site IT39008, Arezzo, , Italy
Site IT39019, Cremona, , Italy
Site IT39010, Milan, , Italy
Site IT39025, Modena, , Italy
Site IT39013, Pisa, , Italy
Site IT39014, Reggio Emilia, , Italy
Site IT39004, Terni, , Italy
Site JP81010, Hirosaki, Aomori, Japan
Site JP81014, Kashiwa, Chiba, Japan
Site JP81007, Sapporo, Hokkaido, Japan
Site JP81026, Sapporo, Hokkaido, Japan
Site JP81020, Tsukuba, Ibaraki, Japan
Site JP81018, Morioka, Iwate, Japan
Site JP81009, Kita-gun, Kagawa, Japan
Site JP81002, Yokohama, Kanagawa, Japan
Site JP81005, Sendai, Miyagi, Japan
Site JP81016, Osakasayama, Osaka, Japan
Site JP81024, Takatsuki, Osaka, Japan
Site JP81008, Bunkyo-ku, Tokyo, Japan
Site JP81012, Koto-ku, Tokyo, Japan
Site JP81013, Shinjuku-ku, Tokyo, Japan
Site JP81011, Ube, Yamaguchi, Japan
Site JP81015, Chiba, , Japan
Site JP81019, Fukuoka, , Japan
Site JP81023, Fukuoka, , Japan
Site JP81004, Hiroshima, , Japan
Site JP81001, Kyoto, , Japan
Site JP81017, Niigata, , Japan
Site JP81003, Okayama, , Japan
Site JP81022, Osaka, , Japan
Site JP81021, Tokushima, , Japan
Site JP81006, Toyama, , Japan
Site KR82006, Daejeon, , Korea, Republic of
Site KR82007, Goyang-Si, , Korea, Republic of
Site KR82012, Hwasun-gun, , Korea, Republic of
Site KR82002, Incheon, , Korea, Republic of
Site KR82001, Seongnam-si, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82008, Seoul, , Korea, Republic of
Site KR82009, Seoul, , Korea, Republic of
Site KR82010, Seoul, , Korea, Republic of
Site KR82005, Shin, , Korea, Republic of
Site NL31002, Amsterdam, , Netherlands
Site NL31003, Amsterdam, , Netherlands
Site NL31009, Nijmegen, , Netherlands
Site NL31001, Tilburg, , Netherlands
Site PT35105, Lisboa, , Portugal
Site PT35102, Lisbon, , Portugal
Site PT35106, Porto, , Portugal
Site RU70002, Ivanovo, , Russian Federation
Site RU70009, Obninsk, , Russian Federation
Site RU70005, Omsk, , Russian Federation
Site RU70015, Vologda, , Russian Federation
Site ES34010, Badajoz, , Spain
Site ES34002, Badalona, , Spain
Site ES34001, Barcelona, , Spain
Site ES34012, Barcelona, , Spain
Site ES34023, Barcelona, , Spain
Site ES34014, Córdoba, , Spain
Site ES34003, Madrid, , Spain
Site ES34013, Madrid, , Spain
Site ES34015, Madrid, , Spain
Site ES34017, Madrid, , Spain
Site ES34011, Manresa, , Spain
Site ES34019, Pamplona, , Spain
Site ES34005, Seville, , Spain
Site ES34007, Valencia, , Spain
Site ES34008, Valencia, , Spain
Site CH41002, Bern, , Switzerland
Site CH41001, Chur, , Switzerland
Site TW88602, Kaohsiung, , Taiwan
Site TW88605, Kaohsiung, , Taiwan
Site TW88606, Taichung, , Taiwan
Site TW88601, Tainan, , Taiwan
Site TW88604, Taipei, , Taiwan
Site TW88607, Taoyuan, , Taiwan
Site GB44005, London, , United Kingdom
Site GB44006, London, , United Kingdom
Site GB44002, Sheffield, , United Kingdom
Site GB44011, Southampton, , United Kingdom
Site GB44013, Sutton, , United Kingdom
Site GB44004, Wirral, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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