RecruitingPhase III🇵🇱 PolandEN originalBladder cancer

An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection. Study details: Duration: \~78 months (6.5 years) from FSI to last subject visit Treatment length: up to \~12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek powyżej 18 lat
  • Potwierdzony nowotwór pęcherza moczowego lub górnych dróg moczowych
  • Przebyta operacja usunięcia nowotworu 28-120 dni przed włączeniem do badania
  • Nowotwór wysokiego ryzyka nawrotu - określony stopień zaawansowania
  • Brak widocznych pozostałości nowotworu w badaniach przedbadaniem
  • Dobry stan ogólny pacjenta (ECOG 0-1)
  • Oczekiwana długość życia ponad 12 tygodni
  • Dostępna próbka tkanki guza do badań laboratoryjnych

✗ Disqualifies

  • Nowotwór zawierający komórki neuroendokrynne
  • Częściowe usunięcie pęcherza lub nerki
  • Poprzednie chemioterapii lub radioterapii po operacji
  • Ciężkie choroby przewlekłe lub historia przeszczepów
  • Historia chorób rogu rogówki oka
  • Inny nowotwór w przeszłości (z wyjątkami)
  • Niestabilne pozostałości po poprzednim leczeniu
  • Niekontrolowana infekcja wirusem zapalenia wątroby B lub C

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (160)

Research Site

Hot Springs, United States

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Little Rock, United States

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Little Rock, United States

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San Francisco, United States

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Chicago, United States

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Boston, United States

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Kansas City, United States

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Lincoln, United States

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Omaha, United States

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Albany, United States

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New York, United States

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Cleveland, United States

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Myrtle Beach, United States

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Nashville, United States

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Dallas, United States

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Falls Church, United States

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Seattle, United States

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Tacoma, United States

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Milwaukee, United States

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Auchenflower, Australia

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Ballarat, Australia

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Clayton, Australia

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Darlinghurst, Australia

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Elizabeth Vale, Australia

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South Brisbane, Australia

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St Albans, Australia

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Barretos, Brazil

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Curitiba, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Canada

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Abbotsford British Columbia, Canada

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Barrie, Canada

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Hamilton, Canada

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Kingston, Canada

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London, Canada

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Mississauga, Canada

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Montreal, Canada

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Montreal, Canada

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Beijing, China

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Beijing, China

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Beijing, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guiyang, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Jinan, China

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Jinan, China

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Kunming, China

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Kunming, China

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Lanzhou, China

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Nanchang, China

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Nanjing, China

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Nanning, China

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Ningbo, China

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Qingdao, China

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Shanghai, China

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Shenyang, China

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Shenyang, China

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Suining Shi, China

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Tianjin, China

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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Xuzhou, China

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Zhengzhou, China

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Bordeaux, France

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Montpellier, France

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Paris, France

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Pierre-Bénite, France

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Poitiers, France

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Strasbourg, France

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Bochum, Germany

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Bonn, Germany

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Dresden, Germany

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Duisburg, Germany

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Frankfurt am Main, Germany

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Hamburg, Germany

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Hanover, Germany

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Herne, Germany

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Magdeburg, Germany

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Mannheim, Germany

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Marburg, Germany

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Mettmann, Germany

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Münster, Germany

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Nuremberg, Germany

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Nürtingen, Germany

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Regensburg, Germany

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Rostock, Germany

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Stuttgart, Germany

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Tübingen, Germany

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Ulm, Germany

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Kolkata, India

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Kottayam, India

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Nashik, India

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Navi Mumbai, India

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New Delhi, India

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New Delhi, India

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New Delhi, India

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Bari, Italy

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Florence, Italy

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Padova, Italy

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Roma, Italy

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Rozzano, Italy

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Tricase, Italy

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Fukuoka, Japan

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Fukuoka, Japan

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Hamamatsu, Japan

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Hirosaki-shi, Japan

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Kanazawa, Japan

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Kashihara-shi, Japan

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Kawasaki-shi, Japan

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Kita-gun, Japan

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Kobe, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Osaka, Japan

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Osaka, Japan

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Toyama, Japan

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Tsukuba, Japan

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Gdansk, Poland

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Koszalin, Poland

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Poznan, Poland

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Siedlce, Poland

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Skórzewo, Poland

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Wroclaw, Poland

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Wroclaw, Poland

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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L'Hospitalet de Llobregat, Spain

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Las Palmas de Gran Canaria, Spain

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Madrid, Spain

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Santander, Spain

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Seville, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkok, Thailand

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Hat Yai, Thailand

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Bristol, United Kingdom

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Cambridge, United Kingdom

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Preston, United Kingdom

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Sheffield, United Kingdom

Trial contact

AstraZeneca Clinical Study Information Center

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.

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