New drug cocktail aims to outperform chemo for advanced bladder cancer

NCT ID NCT04223856

Ongoing Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 study tests whether a combination of two drugs, enfortumab vedotin and pembrolizumab, works better than standard chemotherapy for people with advanced urothelial cancer that has spread. About 886 participants who have not had prior treatment for their advanced cancer are enrolled. The main goals are to see if the combo improves how long people live without their cancer growing and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

enfortumab vedotin and pembrolizumab

What this could lead to

If successful, this combination could become a new first-line treatment option for advanced urothelial cancer, potentially improving survival and delaying disease progression compared to standard chemotherapy.

What could go wrong

This is a phase 3 trial, but results are not yet final. The combination may not prove superior to chemotherapy, and side effects from the two drugs together could be significant.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

UROTHELIAL CANCER

Contacts and locations

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Locations

Arizona Oncology Associates PD - HOPE

Tucson, Arizona, 85710, United States
Cancer Centers of Colorado - Denver

Denver, Colorado, 80218, United States
City of Hope National Medical Center

Duarte, California, 91010, United States
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States
Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute

Marietta, Georgia, 30060, United States
H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States
Hillman Cancer Center / University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States
Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States
Ironwood Cancer & Research Centers - Chandler

Chandler, Arizona, 85224, United States
Johns Hopkins Medical Center

Baltimore, Maryland, 21231, United States
Lombardi Cancer Center / Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Louisiana State University/ East Jefferson General Hospital

Metairie, Louisiana, 70006, United States
Maine Health Cancer Care

Biddeford, Maine, 04046, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States
New York University (NYU) Cancer Institute

New York, New York, 10016, United States
Providence St Joseph Medical Center

Burbank, California, 91505, United States
Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States
Saint Francis Hospital / Bon Secours - South Carolina

Greenville, South Carolina, 29607, United States
Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109, United States
Site AR54001

Rosario, 2000, Argentina
Site AR54002

San Miguel, T400GTB, Argentina
Site AR54003

Viedma, 8500, Argentina
Site AR54004

Mendoza, M5500AYB, Argentina
Site AR54005

Córdoba, X5004FHP, Argentina
Site AR54006

La Rioja, 5300, Argentina
Site AR54008

Buenos Aire, C1019ABS, Argentina
Site AR54011

CABA, C1426ANZ, Argentina
Site AR54012

San Miguel de Tucumán, T4000IAK, Argentina
Site AU61003

Box Hill, 3128, Australia
Site AU61005

South Brisbane, 4101, Australia
Site AUS61001

Douglas, 4814, Australia
Site AUS61002

Macquarie Park, 2109, Australia
Site AUS61004

Heidelberg, 3084, Australia
Site AUS61006

South Australia, 5112, Australia
Site BE32001

Liège, 4000, Belgium
Site BE32002

Ghent, 9000, Belgium
Site BE32003

Brussels, 1200, Belgium
Site BE32006

Roeselare, 8800, Belgium
Site BE32007

Lueven, 3000, Belgium
Site CA11001

Montreal, Quebec, H3T 1E2, Canada
Site CA11002

Hamilton, Ontario, L8V 1C3, Canada
Site CA11003

Edmonton, Alberta, T6G 1Z2, Canada
Site CA11004

Calgary, Alberta, T2N 4N2, Canada
Site CA11005

Toronto, Ontario, M5G 2M9, Canada
Site CA11006

Vancouver, British Columbia, V5Z 4E6, Canada
Site CA11008

Québec, G1R 2J6, Canada
Site CA11009

London, Ontario, N6A 5A5, Canada
Site CA11010

Montreal, Quebec, H2X 0A9, Canada
Site CA11011

Oshawa, Ontario, L1G 2B9, Canada
Site CA11012

Toronto, Ontario, M4N 3M5, Canada
Site CH41001

Chur, 7000, Switzerland
Site CH41002

Bern, 3010, Switzerland
Site CH41003

Winterthur, 8401, Switzerland
Site CH41004

Basel, 4031, Switzerland
Site CN86001

Beijing, 100036, China
Site CN86002

Guangzhou, 510120, China
Site CN86003

Changchun, 130021, China
Site CN86004

Beijing, 100050, China
Site CN86005

Beijing, 100191, China
Site CN86006

Changsha, 410013, China
Site CN86007

Chongqing, 400038, China
Site CN86008

Wuhan, 430030, China
Site CN86009

Beijing, 100021, China
Site CN86010

Chengdu, 610041, China
Site CN86011

Shenyang, 110022, China
Site CN86012

Nanjing, 210029, China
Site CN86013

Hangzhou, 310014, China
Site CN86014

Shanghai, 200040, China
Site CN86015

Bengbu, 233000, China
Site CN86016

Changsha, 410013, China
Site CN86017

Nanjing, 210008, China
Site CN86018

Hangzhou, 0571, China
Site CN86019

Tianjin, 453000, China
Site CN86020

Gunagzhou, 510280, China
Site CN86021

Ningbo, 315016, China
Site CN86022

Hangzhou, 310016, China
Site CN86023

Tianjin, 300052, China
Site CN86024

Chongqing, 400030, China
Site CN86025

Hefei, 400030, China
Site CN86026

Xuzhou, 221009, China
Site CN86027

Jinan, 250021, China
Site CN86028

Fuzhou, 350005, China
Site CN86029

Wenzhou, 325000, China
Site CN86030

Xicheng District, 100034, China
Site CZ42001

Hradec Králové, 500 05, Czechia
Site CZ42004

Olomouc, 779 00, Czechia
Site CZ42005

Praha 4-Krc, 140 59, Czechia
Site CZ42006

Brno, 656 91, Czechia
Site DE49001

Lübeck, 23538, Germany
Site DE49002

München, 81675, Germany
Site DE49003

Berlin, 10117, Germany
Site DE49004

Tübingen, 72076, Germany
Site DE49005

Heidelberg, 69120, Germany
Site DE49006

Jena, 07747, Germany
Site DE49007

Frankfurt am Main, 60488, Germany
Site DE49008

Magdeburg, 39120, Germany
Site DE49009

Herne, 44649, Germany
Site DE49010

Ulm, 89081, Germany
Site DE49011

Essen, 45147, Germany
Site DE49012

Mannheim, 68167, Germany
Site DE49013

Bielefeld, 33611, Germany
Site DE49014

Erlangen, 91054, Germany
Site DE49015

Göttingen, 37099, Germany
Site DE49016

Düsseldorf, 40225, Germany
Site DK45001

Aalborg, 9100, Denmark
Site DK45003

Aarhus N, 8200, Denmark
Site ES34001

Barcelona, 08041, Spain
Site ES34002

Madrid, 28034, Spain
Site ES34003

Madrid, 28040, Spain
Site ES34004

Manresa, 08243, Spain
Site ES34006

Barcelona, 08036, Spain
Site ES34007

Seville, 41013, Spain
Site ES34008

Barcelona, 08907, Spain
Site ES34009

Valencia, 46014, Spain
Site ES34010

Barcelona, 08035, Spain
Site ES34012

Santander, 39008, Spain
Site ES34013

Córdoba, 14004, Spain
Site ES34015

Madrid, 28041, Spain
Site ES34016

Sabadell, 08208, Spain
Site ES34017

Barcelona, 08003, Spain
Site ES34018

Madrid, 28007, Spain
Site ES34019

Valencia, 46009, Spain
Site ES34020

Pamplona, 31008, Spain
Site ES34021

Lugo, 27003, Spain
Site FR33003

Nice, 06189, France
Site FR33011

Villejuif-Cedex-France, 94805, France
Site FR33013

Strasbourg, 67200, France
Site FR33014

Bordeaux, 33000, France
Site FR33016

Lyon, 69373, France
Site FR33017

Tours, 37044, France
Site FR33020

Pierre-Bénite, 69495, France
Site HU36001

Nyíregyháza, 4400, Hungary
Site HU36002

Budapest, 1122, Hungary
Site HU36003

Budapest, 1083, Hungary
Site HU36005

Szolnok, 5004, Hungary
Site HU36006

Debrecen, 4032, Hungary
Site IL97201

Haifa, 31096, Israel
Site IL97202

Kfar Saba, 44281, Israel
Site IL97203

Beersheba, 84101, Israel
Site IL97204

Tel Litwinsky, 52621, Israel
Site IL97205

Ẕerifin, 70300, Israel
Site IL97206

Jerusalem, 91120, Israel
Site IL97208

Petah Tikva, 49414, Israel
Site IL97209

Holon, 58100, Israel
Site IL97210

Tel Aviv, 64239, Israel
Site IL97211

Rehovot, 76100, Israel
Site IT39001

Verona, 37134, Italy
Site IT39002

Terni, 05100, Italy
Site IT39003

Meldola, 47014, Italy
Site IT39004

Pisa, 56126, Italy
Site IT39005

Areezo, 52100, Italy
Site IT39006

Genova, 16132, Italy
Site IT39007

Milan, 20141, Italy
Site IT39008

Candiolo, 10060, Italy
Site IT39009

Cremona, 26100, Italy
Site IT39011

Torrette, 60126, Italy
Site IT39014

Milan, 20132, Italy
Site JP81001

Kōtoku, Japan
Site JP81002

Bunkyō City, Japan
Site JP81003

Toyama, Japan
Site JP81004

Tsukuba, Japan
Site JP81005

Okayama, Japan
Site JP81006

Kawasaki-shi, Japan
Site JP81007

Sapporo, Japan
Site JP81008

Osaka, Japan
Site JP81009

Chiba, Japan
Site JP81010

Ube, Japan
Site JP81011

Hirosaki, Japan
Site JP81012

Sendai, Japan
Site JP81013

Fukuoka, Japan
Site JP81014

Tokushima, Japan
Site JP81015

Niigata, Japan
Site JP81016

Osakasayama-Shi, Japan
Site JP81017

Kyoto, Japan
Site JP81018

Chiba, Japan
Site JP81019

Tokyo, Japan
Site JP81020

Fukuoka, Japan
Site KR82001

Daejeon, 301-721, South Korea
Site KR82002

Goyang-si, 10408, South Korea
Site KR82003

Seoul, 03722, South Korea
Site KR82004

Seongnam-si, 13605, South Korea
Site KR82005

Seoul, 05505, South Korea
Site KR82006

Seoul, 137-701, South Korea
Site KR82007

Seoul, 135-710, South Korea
Site KR82008

Hwasun, 519-763, South Korea
Site NL31001

Amsterdam, 1081 HV, Netherlands
Site NL31002

Amsterdam, 1066 CX, Netherlands
Site NL31003

Rotterdam, 3075 EA, Netherlands
Site NL31004

Nieuwegein, 3435 CM, Netherlands
Site NL31005

Amsterdam, Noord-Holland, 1066 CX, Netherlands
Site NL31006

Utrecht, 3584 CX, Netherlands
Site NL31007

Leeuwarden, 8934 AD, Netherlands
Site PL48002

Warsaw, 01-748, Poland
Site RU70002

Omsk, 644013, Russia
Site RU70003

Moscow, 125284, Russia
Site RU70004

Moscow, 105077, Russia
Site RU70005

Ufa, 450000, Russia
Site RU70006

Leningradskaya Oblast', 188663, Russia
Site RU70007

Saint Petersburg, 197082, Russia
Site RU70008

Saint Petersburg, 197758, Russia
Site RU70009

Saransk, 430032, Russia
Site RU70010

Saint Petersburg, 195271, Russia
Site RU70011

Moscow, 123056, Russia
Site RU70012

Saint Petersburg, 197758, Russia
Site RU70013

Barnaul, 656049, Russia
Site RU70014

Krasnoyarsk, 660133, Russia
Site RU70015

Tyumen, 625041, Russia
Site RU70016

Arkhangelsk, 163045, Russia
Site RU70017

Nizhny Novgorod, 603074, Russia
Site RU70019

Pyatigorsk, 357502, Russia
Site RU70020

Ivanovo, 153040, Russia
Site SG65001

Singapore, 119074, Singapore
Site SG65002

Singapore, 169610, Singapore
Site SG65003

Singapore, 308433, Singapore
Site TH66001

Ratchathewi, 10400, Thailand
Site TH66002

Hat Yai, 90110, Thailand
Site TH66003

Bangkok, 10400, Thailand
Site TH66004

Bangkok, 10330, Thailand
Site TH66005

Chiang Mai, 50200, Thailand
Site TH66006

Bangkok, 10700, Thailand
Site TH66007

Muang, 40002, Thailand
Site TR90001

Konya, 42080, Turkey (Türkiye)
Site TR90002

Istanbul, 81450, Turkey (Türkiye)
Site TR90003

Istanbul, 34214, Turkey (Türkiye)
Site TR90004

Edirne, 22030, Turkey (Türkiye)
Site TR90005

Antalya, 07059, Turkey (Türkiye)
Site TR90006

Malatya, 44280, Turkey (Türkiye)
Site TR90007

Ankara, 6100, Turkey (Türkiye)
Site TR90008

Istanbul, 34093, Turkey (Türkiye)
Site TR90009

Ankara, 6230, Turkey (Türkiye)
Site TW88601

Taipei, 11217, Taiwan
Site TW88602

Kweishan, 333, Taiwan
Site TW88603

Kaohsiung City, 83301, Taiwan
Site TW88604

Tainan, 70403, Taiwan
Site TW88605

Taipei, 10002, Taiwan
Site TW88606

Taichung, 40705, Taiwan
Site TW88607

Taichung, 40447, Taiwan
Site UK44001

London, EC1M 6BQ, United Kingdom
Site UK44002

Preston, PR2 9HT, United Kingdom
Site UK44003

Sheffield, S10 2RX, United Kingdom
Site UK44005

Glasgow, G12 0YN, United Kingdom
Site UK44006

Oxford, OX3 7LE, United Kingdom
Site UK44008

Southampton, SO16 6YD, United Kingdom
Site UK44009

London, W6 8RF, United Kingdom
Site UK44010

Plymouth, PL6 8DH, United Kingdom
The Cleveland Clinic

Cleveland, Ohio, 44195, United States
Toledo Clinic Cancer Center

Toledo, Ohio, 43623, United States
UT Health East Texas Hope Cancer Center

Tyler, Texas, 75701, United States
University of California Irvine - Newport

Orange, California, 92868, United States
University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States
University of Colorado Hospital / University of Colorado

Aurora, Colorado, 80045, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Virginia

Charlottesville, Virginia, 22908, United States
Vidant Medical Center

Greenville, North Carolina, 27834, United States
West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States
Winship Cancer Institute / Emory University School of Medicine

Atlanta, Georgia, 30322, United States
Yale Cancer Center

New Haven, Connecticut, 06520, United States