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
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 caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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

    Contact Us
    Contact Us
    Active, not recruiting
    Site AT43005
    Linz, Austria
    Completed
    Innovative Clinical Research
    Whittier, CA, United States, 90606
    Completed
    Site JP81023
    Fukuoka, Fukuoka, Japan
    Active, not recruiting
    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
    Active, not recruiting
    Site AU61002
    Sydney, Australia
    Completed
    Montefiore Medical Center
    Bronx, NY, United States, 10467
    Active, not recruiting
    Site DK45003
    Aalborg, Denmark
    Completed
    Site ES34005
    Seville, Spain
    Active, not recruiting
    Site CA15013
    Vancouver, Canada
    Completed
    University of California
    Sacramento, CA, United States, 95817
    Active, not recruiting
    Providence Portland Med Center
    Portland, OR, United States, 97213
    Completed
    Site RU70005
    Omsk, Russian Federation
    Completed
    Site JP81004
    Hiroshima, Hiroshima, Japan
    Active, not recruiting
    Site DE49008
    Heidelberg, Germany
    Completed
    Site ES34008
    Valencia, Spain
    Completed
    Site ES34002
    Badalona, Spain
    Active, not recruiting
    Site CA15015
    Calgary, Canada
    Completed
    Site ES34023
    Barcelona, Spain
    Completed
    Site CA15001
    Sherbrooke, Canada
    Completed
    Site CH41001
    Chur, Switzerland
    Active, not recruiting
    Site IT39013
    Pisa, Italy
    Completed
    Site IT39025
    Modena, Italy
    Withdrawn
    Fairview Ridges Specialty Center
    Burnsville, MN, United States, 55337
    Active, not recruiting
    Site FR33022
    Paris, France
    Completed
    Site BE32010
    Charleroi, Belgium
    Completed
    Site JP81013
    Shinjuku-ku, Tokyo, Japan
    Active, not recruiting
    Site JP81012
    Koto-ku, Tokyo, Japan
    Active, not recruiting
    Site JP81011
    Ube, Yamaguchi, Japan
    Active, not recruiting
    Site GB44011
    Southampton, United Kingdom
    Completed
    Site JP81002
    Yokohama, Kanagawa, Japan
    Active, not recruiting
    Site JP81014
    Kashiwa, Chiba, Japan
    Active, not recruiting
    Site ES34019
    Pamplona, Spain
    Active, not recruiting
    Site GB44004
    Wirral, United Kingdom
    Completed
    Site BE32011
    Aalst, Belgium
    Withdrawn
    Allina Health System
    Minneapolis, MN, United States, 55407
    Completed
    Site ES34003
    Madrid, Spain
    Active, not recruiting
    Medical College of Wisconsin
    Milwaukee, WI, United States, 53226
    Active, not recruiting
    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
    Active, not recruiting
    Site GB44005
    London, United Kingdom
    Active, not recruiting
    Site FR33001
    Brest, France
    Active, not recruiting
    Site FR33014
    Marseille, France
    Completed
    Site CA15014
    London, Canada
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    Site TW88607
    Taoyuan, Taiwan, Province of China
    Completed
    Site JP81026
    Sapporo, Hokkaido, Japan
    Active, not recruiting
    Site AU61001
    Miranda, Australia
    Completed
    Site ES34012
    Barcelona, Spain
    Active, not recruiting
    Site JP81010
    Hirosaki, Aomori, Japan
    Active, not recruiting
    Site DE49003
    Tübingen, Germany
    Completed
    Toledo Clinic Cancer Center
    Toledo, OH, United States, 43623
    Completed
    Site IT39019
    Cremona, Italy
    Active, not recruiting
    Sidney Kimmel Center for Prostate and Urologic Cancers
    New York City, NY, United States, 10065
    Completed
    Site IT39014
    Reggio Emilia, Italy
    Active, not recruiting
    Site JP81005
    Sendai, Miyagi, Japan
    Withdrawn
    Site GB44008
    Manchester, United Kingdom
    Active, not recruiting
    Site PT35106
    Porto, Portugal
    Completed
    Site AR54001
    Buenos Aires, Argentina
    Completed
    University of Colorado
    Denver, CO, United States, 80045
    Withdrawn
    Site CA15017
    Kelowna, Canada
    Active, not recruiting
    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
    Active, not recruiting
    Site TW88605
    Kaohsiung, Taiwan, Province of China
    Completed
    Site GB44013
    Sutton, United Kingdom
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    University of Pennsylvania
    Philadelphia, PA, United States, 19104
    Completed
    Site CA15011
    Oshawa, Canada
    Active, not recruiting
    Site KR82003
    Seoul, Republic of Korea
    Active, not recruiting
    Site IT39004
    Terni, Italy
    Completed
    Site JP81003
    Okayama, Okayama, Japan
    Active, not recruiting
    Site JP81017
    Niigata, Niigata, Japan
    Active, not recruiting
    Site BE32008
    Gent, Belgium
    Active, not recruiting
    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
    Active, not recruiting
    Site ES34015
    Madrid, Spain
    Completed
    Site AU61004
    St. Leonards, Australia
    Active, not recruiting
    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
    Active, not recruiting
    Site FR33002
    Strasbourg, France
    Completed
    Site IT39008
    Arezzo, Italy
    Completed
    Lifespan Rhode Island Hospital
    Providence, RI, United States, 02903
    Completed
    Site PT35102
    Lisbon, Portugal
    Active, not recruiting
    Site FR33016
    Caen, France
    Withdrawn
    Site AR54003
    Buenos Aires, Argentina
    Withdrawn
    Alaska Clinical Research Center
    Anchorage, AK, United States, 99508
    Active, not recruiting
    Site BE32001
    Gent, Belgium
    Active, not recruiting
    Site KR82006
    Daejeon, Republic of Korea
    Active, not recruiting
    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
    Active, not recruiting
    Site JP81006
    Toyama, Toyama, Japan
    Withdrawn
    Site AR54002
    San Miguel de Tucumán, Argentina
    Active, not recruiting
    Site FR33015
    Lyon, France
    Active, not recruiting
    Site TW88601
    Tainan, Taiwan, Province of China
    Completed
    Site ES34001
    Barcelona, Spain
    Withdrawn
    Site CA15003
    Hamilton, Canada
    Active, not recruiting
    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
    Active, not recruiting
    Site CA15005
    Toronto, Canada
    Active, not recruiting
    Site KR82010
    Seoul, Republic of Korea
    Completed
    Site AT43001
    Salzburg, Austria
    Active, not recruiting
    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
    Active, not recruiting
    Site FR33003
    Nice, France
    Withdrawn
    Site AU61003
    Douglas, Australia
    Active, not recruiting
    White Plains Hospital Center for Cancer Care – Oncology Site
    White Plains, NY, United States, 10601
    Active, not recruiting
    Site DK45001
    Herlev, Denmark
    Completed
    Site ES34010
    Badajoz, Spain
    Withdrawn
    Queens Medical Associates
    Fresh Meadows, NY, United States, 11366-1531
    Active, not recruiting
    Site DE49010
    Munster, 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
    Active, not recruiting
    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
    Active, not recruiting
    Dana-Farber Cancer Institute
    Boston, MA, United States, 02215
    Active, not recruiting
    Benaroya Research Institute at Virginia Mason
    Seattle, WA, United States, 98101
    Active, not recruiting
    Site JP81024
    Takatsuki, Osaka, Japan
    Completed
    Florida Hospital
    Orlando, FL, United States, 32804
    Active, not recruiting
    Site CA15004
    Quebec, Canada
    Active, not recruiting
    Site BE32005
    Hasselt, Belgium
    Completed
    Site JP81009
    Kita-gun, Kagawa, Japan
    Active, not recruiting
    Site DK45004
    Copenhagen, Denmark
    Active, not recruiting
    Site KR82005
    Shin, Republic of Korea
    Completed
    Site DE49011
    Essen, Germany
    Active, not recruiting
    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
    Active, not recruiting
    Site KR82007
    Goyang-Si, Republic of Korea
    Completed
    Site CA15012
    Edmonton, Canada
    Completed
    Site KR82009
    Seoul, Republic of Korea
    Withdrawn
    Site DE49013
    Dresden, Germany
    Active, not recruiting
    Long Island Jewish Medical Center
    Lake Success, NY, United States, 11042
    Active, not recruiting
    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.

    Will I have to stop my current treatment to participate in a clinical trial?

    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.

    Explore More

    1

    What are clinical trials?

    2

    Why are Clinical Trials Important?

    3

    Why Participate in a Clinical Trial?