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ACTIVE NOT RECRUITING
NCT04223856
PHASE3

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Enfortumab vedotin

Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle

DRUG

Pembrolizumab

IV infusion on Day 1 of every 3-week cycle

DRUG

Cisplatin

administered as IV infusion on Day 1 of each 3-week cycle

DRUG

Carboplatin

Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle

DRUG

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

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Site AR54005

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Site AR54006

La Rioja, Argentina

Site AR54004

Mendoza, Argentina

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San Miguel, Argentina

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Viedma, Argentina

Site AU61003

Box Hill, Australia

Site AUS61001

Douglas, Australia

Site AUS61004

Heidelberg, Australia

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Macquarie Park, Australia

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South Australia, Australia

Site AU61005

South Brisbane, Australia

Site BE32003

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Roeselare, Belgium

Site CA11004

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Site CN86009

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Site CN86024

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Site CN86007

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Site CN86028

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Site CN86002

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Site CN86020

Gunagzhou, China

Site CN86018

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Site CN86013

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Hangzhou, China

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Site CN86027

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Site CN86017

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Site CN86012

Nanjing, China

Site CN86021

Ningbo, China

Site CN86014

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Site CN86011

Shenyang, China

Site CN86023

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Site CN86019

Tianjin, China

Site CN86029

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Site CN86008

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Site CN86030

Xicheng District, China

Site CN86026

Xuzhou, China

Site CZ42006

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Site DK45001

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Site FR33014

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Site FR33016

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Site FR33020

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Site FR33013

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Site FR33017

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Site FR33011

Villejuif-Cedex-France, France

Site DE49003

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Site DE49013

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Site DE49016

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Site DE49014

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Site DE49011

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Site DE49007

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Site DE49015

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Site DE49005

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Site DE49009

Herne, Germany

Site DE49006

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Site DE49001

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Mannheim, Germany

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Site DE49004

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Site DE49010

Ulm, Germany

Site HU36003

Budapest, Hungary

Site HU36002

Budapest, Hungary

Site HU36006

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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

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Site IT39006

Genova, Italy

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Meldola, Italy

Site IT39014

Milan, Italy

Site IT39007

Milan, Italy

Site IT39004

Pisa, Italy

Site IT39002

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Site IT39011

Torrette, Italy

Site IT39001

Verona, Italy

Site JP81002

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Site JP81009

Chiba, Japan

Site JP81018

Chiba, Japan

Site JP81013

Fukuoka, Japan

Site JP81020

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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

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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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

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Site TW88601

Taipei, Taiwan

Site TH66004

Bangkok, Thailand

Site TH66003

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Site TH66006

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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