Study 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.

Additional Study Details

Phase
Phase 3
Product
  • Enfortumab Vedotin
  • Docetaxel
  • Vinflunine
  • Paclitaxel
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    608
    Show Additional Study Details

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A Study to Evaluate Enfortumab Vedotin versus (vs) Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

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      Completed
      Site AT43005
      Linz, Austria
      Completed
      Innovative Clinical Research
      Whittier, CA, United States, 90606
      Completed
      Site JP81023
      Fukuoka, Fukuoka, Japan
      Completed
      Fox Chase Cancer Center
      Philadelphia, PA, United States, 19111
      Completed
      Site JP81001
      Kyoto, Kyoto, Japan
      Completed
      Site NL31001
      Tilburg, Netherlands
      Completed
      HOPE Cancer Center of East Texas
      Tyler, TX, United States, 75701
      Completed
      Site AU61002
      Sydney, Australia
      Completed
      Montefiore Medical Center
      Bronx, NY, United States, 10467
      Completed
      Site DK45003
      Aalborg, Denmark
      Completed
      Site ES34005
      Seville, Spain
      Completed
      Site CA15013
      Vancouver, Canada
      Completed
      University of California
      Sacramento, CA, United States, 95817
      Completed
      Providence Portland Med Center
      Portland, OR, United States, 97213
      Completed
      Site RU70005
      Omsk, Russian Federation
      Completed
      Site JP81004
      Hiroshima, Hiroshima, Japan
      Completed
      Site DE49008
      Heidelberg, Germany
      Completed
      Site ES34008
      Valencia, Spain
      Completed
      Site ES34002
      Badalona, Spain
      Completed
      Site CA15015
      Calgary, Canada
      Completed
      Site ES34023
      Barcelona, Spain
      Completed
      Site CA15001
      Sherbrooke, Canada
      Completed
      Site CH41001
      Chur, Switzerland
      Completed
      Site IT39013
      Pisa, Italy
      Completed
      Site IT39025
      Modena, Italy
      Withdrawn
      Fairview Ridges Specialty Center
      Burnsville, MN, United States, 55337
      Completed
      Site FR33022
      Paris, France
      Completed
      Site BE32010
      Charleroi, Belgium
      Completed
      Site JP81013
      Shinjuku-ku, Tokyo, Japan
      Completed
      Site JP81012
      Koto-ku, Tokyo, Japan
      Completed
      Site JP81011
      Ube, Yamaguchi, Japan
      Completed
      Site GB44011
      Southampton, United Kingdom
      Completed
      Site JP81002
      Yokohama, Kanagawa, Japan
      Completed
      Site JP81014
      Kashiwa, Chiba, Japan
      Completed
      Site ES34019
      Pamplona, Spain
      Completed
      Site GB44004
      Wirral, United Kingdom
      Completed
      Site BE32011
      Aalst, Belgium
      Withdrawn
      Allina Health System
      Minneapolis, MN, United States, 55407
      Completed
      Site ES34003
      Madrid, Spain
      Completed
      Medical College of Wisconsin
      Milwaukee, WI, United States, 53226
      Completed
      Site ES34017
      Madrid, Spain
      Completed
      Site NL31003
      Amsterdam, Netherlands
      Completed
      Site KR82012
      Hwasun-gun, Republic of Korea
      Active, not recruiting
      Site PT35105
      Lisboa, Portugal
      Completed
      Site KR82001
      Seongnam-si, Republic of Korea
      Completed
      Site GB44005
      London, United Kingdom
      Completed
      Site FR33001
      Brest, France
      Completed
      Site FR33014
      Marseille, France
      Completed
      Site CA15014
      London, Canada
      Completed
      UCI Chao Family Comprehensive Cancer Center
      Orange, CA, United States, 92868
      Withdrawn
      Site BE32002
      Roeselare, Belgium
      Completed
      Site GB44002
      Sheffield, United Kingdom
      Completed
      Site JP81016
      Osakasayama, Osaka, Japan
      Withdrawn
      Site ES34006
      Madrid, Spain
      Withdrawn
      Site IT39023
      Lucca, Italy
      Active, not recruiting
      Site ES34014
      Córdoba, Spain
      Completed
      Site FR33009
      Bordeaux, France
      Completed
      Site CA15007
      Montreal, Canada
      Withdrawn
      Site IT39018
      Turin, Italy
      Completed
      Site NL31002
      Amsterdam, Netherlands
      Withdrawn
      Site IT39026
      Moldova, Italy
      Completed
      Site JP81018
      Morioka, Iwate, Japan
      Completed
      Site JP81007
      Sapporo, Hokkaido, Japan
      Completed
      Site BE32003
      Leuven, Belgium
      Withdrawn
      Site FR33020
      Montpellier, France
      Completed
      Site TW88607
      Taoyuan, Taiwan, Province of China
      Completed
      Site JP81026
      Sapporo, Hokkaido, Japan
      Completed
      Site AU61001
      Miranda, Australia
      Completed
      Site ES34012
      Barcelona, Spain
      Completed
      Site JP81010
      Hirosaki, Aomori, Japan
      Completed
      Site DE49003
      Tübingen, Germany
      Completed
      Toledo Clinic Cancer Center
      Toledo, OH, United States, 43623
      Completed
      Site IT39019
      Cremona, Italy
      Completed
      Sidney Kimmel Center for Prostate and Urologic Cancers
      New York City, NY, United States, 10065
      Completed
      Site IT39014
      Reggio Emilia, Italy
      Completed
      Site JP81005
      Sendai, Miyagi, Japan
      Withdrawn
      Site GB44008
      Manchester, United Kingdom
      Completed
      Site PT35106
      Porto, Portugal
      Completed
      Site AR54001
      Buenos Aires, Argentina
      Completed
      University of Colorado
      Denver, CO, United States, 80045
      Withdrawn
      Site CA15017
      Kelowna, Canada
      Completed
      Site KR82004
      Seoul, Republic of Korea
      Completed
      Site FR33004
      Saint-Mande, France
      Withdrawn
      Site ES34024
      Santander, Spain
      Withdrawn
      Dayton Physicians LLC
      Dayton, OH, United States, 45430
      Withdrawn
      Medical Oncology Associates, PS
      Spokane, WA, United States, 99208
      Completed
      Site JP81008
      Bunkyo-ku, Tokyo, Japan
      Completed
      Site TW88605
      Kaohsiung, Taiwan, Province of China
      Completed
      Site GB44013
      Sutton, United Kingdom
      Completed
      Smilow Cancer Hospital at Yale-New Haven
      New Haven, CT, United States, 06510
      Withdrawn
      Providence St. Mary Regional Center
      Lacey, WA, United States, 98503
      Completed
      Site CA15008
      Saskatoon, Canada
      Completed
      Site ES34011
      Manresa, Spain
      Completed
      Site IT39010
      Milan, Italy
      Completed
      Site RU70009
      Obninsk, Russian Federation
      Completed
      Site AU61006
      Adelaide, Australia
      Completed
      Roswell Park Cancer Institute
      Buffalo, NY, United States, 14263
      Completed
      University of Pennsylvania
      Philadelphia, PA, United States, 19104
      Completed
      Site CA15011
      Oshawa, Canada
      Completed
      Site KR82003
      Seoul, Republic of Korea
      Completed
      Site IT39004
      Terni, Italy
      Completed
      Site JP81003
      Okayama, Okayama, Japan
      Completed
      Site JP81017
      Niigata, Niigata, Japan
      Completed
      Site BE32008
      Gent, Belgium
      Completed
      Site AT43004
      Wien, Austria
      Completed
      Site RU70015
      Vologda, Russian Federation
      Completed
      Site FR33019
      Toulouse, France
      Completed
      Site FR33021
      Besancon, France
      Withdrawn
      Site IT39027
      Rome, Italy
      Completed
      Site CH41002
      Bern, Switzerland
      Completed
      Site ES34015
      Madrid, Spain
      Completed
      Site AU61004
      St. Leonards, Australia
      Completed
      Site FR33005
      Pierre-Bénite, France
      Completed
      Nebraska Cancer Specialists
      Omaha, NE, United States, 68130
      Withdrawn
      Site FR33012
      Paris, France
      Completed
      Saint Francis Hospital
      Greenville, SC, United States, 29607
      Completed
      Site TW88604
      Taipei, Taiwan, Province of China
      Completed
      Site FR33002
      Strasbourg, France
      Completed
      Site IT39008
      Arezzo, Italy
      Completed
      Lifespan Rhode Island Hospital
      Providence, RI, United States, 02903
      Completed
      Site PT35102
      Lisbon, Portugal
      Completed
      Site FR33016
      Caen, France
      Withdrawn
      Site AR54003
      Buenos Aires, Argentina
      Withdrawn
      Alaska Clinical Research Center
      Anchorage, AK, United States, 99508
      Completed
      Site BE32001
      Gent, Belgium
      Completed
      Site KR82006
      Daejeon, Republic of Korea
      Completed
      Site KR82002
      Incheon, Republic of Korea
      Completed
      Site DE49009
      Würzburg, Germany
      Completed
      Site CA15002
      Montreal, Canada
      Withdrawn
      Site BE32012
      Yvoir, Belgium
      Completed
      Site JP81022
      Osaka, Osaka, Japan
      Withdrawn
      Site CH41003
      Winterthur, Switzerland
      Completed
      Site JP81006
      Toyama, Toyama, Japan
      Withdrawn
      Site AR54002
      San Miguel de Tucumán, Argentina
      Completed
      Site FR33015
      Lyon, France
      Completed
      Site TW88601
      Tainan, Taiwan, Province of China
      Completed
      Site ES34001
      Barcelona, Spain
      Withdrawn
      Site CA15003
      Hamilton, Canada
      Completed
      Site TW88606
      Taichung, Taiwan, Province of China
      Completed
      Site ES34013
      Madrid, Spain
      Withdrawn
      The Oncology Institute of Hope
      Corona, CA, United States, 92882
      Terminated
      Rush University Medical Center
      Chicago, IL, United States, 60612
      Completed
      Site JP81021
      Tokushima, Tokushima, Japan
      Completed
      Site CA15005
      Toronto, Canada
      Completed
      Site KR82010
      Seoul, Republic of Korea
      Completed
      Site AT43001
      Salzburg, Austria
      Completed
      Norton Cancer Institute
      Louisville, KY, United States, 40207
      Withdrawn
      Site ES34022
      Santiago de Compostela, Spain
      Withdrawn
      Site IT39006
      San Giovanni Rotondo, Italy
      Withdrawn
      Site ES34020
      Oviedo, Spain
      Completed
      Site BE32013
      Brussels, Belgium
      Completed
      Site FR33003
      Nice, France
      Withdrawn
      Site AU61003
      Douglas, Australia
      Completed
      White Plains Hospital Center for Cancer Care – Oncology Site
      White Plains, NY, United States, 10601
      Completed
      Site DK45001
      Herlev, Denmark
      Completed
      Site ES34010
      Badajoz, Spain
      Withdrawn
      Queens Medical Associates
      Fresh Meadows, NY, United States, 11366-1531
      Completed
      Site DE49010
      Münster, Germany
      Completed
      Site ES34007
      Valencia, Spain
      Completed
      Site KR82008
      Seoul, Republic of Korea
      Completed
      Site TW88602
      Kaohsiung, Taiwan, Province of China
      Withdrawn
      UMass Memorial Medical Center
      Worcester, MA, United States, 01605
      Completed
      Site RU70002
      Ivanovo, Russian Federation
      Withdrawn
      Piedmont Cancer Institute
      Atlanta, GA, United States, 30318
      Completed
      Site GB44006
      London, United Kingdom
      Withdrawn
      W.G. Hefner VA Medical Center
      Salisbury, NC, United States, 28144
      Completed
      Site JP81015
      Chiba, Chiba, Japan
      Completed
      Site NL31009
      Nijmegen, Netherlands
      Completed
      Site FR33006
      Villejuif, France
      Completed
      Sylvester Comprehensive Cancer Center
      Miami, FL, United States, 33136
      Completed
      Dana-Farber Cancer Institute
      Boston, MA, United States, 02215
      Completed
      Benaroya Research Institute at Virginia Mason
      Seattle, WA, United States, 98101
      Completed
      Site JP81024
      Takatsuki, Osaka, Japan
      Completed
      Florida Hospital
      Orlando, FL, United States, 32804
      Completed
      Site CA15004
      Quebec, Canada
      Completed
      Site BE32005
      Hasselt, Belgium
      Completed
      Site JP81009
      Kita-gun, Kagawa, Japan
      Completed
      Site DK45004
      Copenhagen, Denmark
      Completed
      Site KR82005
      Shin, Republic of Korea
      Completed
      Site DE49011
      Essen, Germany
      Completed
      Site JP81019
      Fukuoka, Fukuoka, Japan
      Withdrawn
      Ochsner Clinic Foundation
      New Orleans, LA, United States, 70121
      Completed
      Site BE32007
      Brussels, Belgium
      Completed
      Site FR33018
      Bordeaux, France
      Completed
      Site BE32009
      Liège, Belgium
      Completed
      Site KR82007
      Goyang-Si, Republic of Korea
      Completed
      Site CA15012
      Edmonton, Canada
      Completed
      Site KR82009
      Seoul, Republic of Korea
      Withdrawn
      Site DE49013
      Dresden, Germany
      Completed
      Long Island Jewish Medical Center
      Lake Success, NY, United States, 11042
      Completed
      Site JP81020
      Tsukuba, Ibaraki, Japan

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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      What are clinical trials?

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      Why Participate in a Clinical Trial?