Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
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
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment. This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci mający ukończone 18 lat.
- •Potwierdzony rak dróg moczowych (pęcherza, miedniczki nerkowej, moczowodu, cewki moczowej), który jest nieoperacyjny lub rozsiany.
- •Pacjenci z rakiem dróg moczowych o mieszanym typie komórek są dopuszczeni, jeśli przeważają komórki nabłonka dróg moczowych.
- •Dopuszczalni są pacjenci z rakiem dróg moczowych i przebytym rakiem prostaty, który nie jest obecnie aktywny i nie dał przerzutów, a poziom PSA jest stabilny.
- •Dopuszczalni są pacjenci z wczesnym rakiem dróg moczowych, którzy nie zareagowali na wcześniejsze leczenie (EV plus pembrolizumab) i rozwinęła się choroba w ciągu 12 miesięcy od zakończenia leczenia (wymaga zgody sponsora).
- •Pacjenci muszą dostarczyć próbkę tkanki guza do badań (z archiwalnych lub nowo pobranych).
✗ Disqualifies
- •Nie dopuszcza się pacjentów z rakiem pęcherza o budowie gruczołowej lub z raka śluzakowatego.
- •Nie dopuszcza się pacjentów z rakiem prostaty z przerzutami.
- •Pacjenci otrzymujący aktualnie terapię hormonalną z powodu raka prostaty są wykluczeni.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (100)
Research Site
Fullerton, United States
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Glendale, United States
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La Jolla, United States
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Los Angeles, United States
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Orange, United States
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San Francisco, United States
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Aurora, United States
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Orange City, United States
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St. Petersburg, United States
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Tamarac, United States
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Atlanta, United States
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Locust Grove, United States
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Effingham, United States
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Niles, United States
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Peoria, United States
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Largo, United States
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Boston, United States
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Grand Rapids, United States
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Rochester, United States
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St Louis, United States
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New York, United States
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Chapel Hill, United States
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Raleigh, United States
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Portland, United States
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Monroeville, United States
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Philadelphia, United States
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Providence, United States
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Myrtle Beach, United States
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Germantown, United States
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Memphis, United States
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Nashville, United States
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Austin, United States
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Dallas, United States
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Dallas, United States
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Charlottesville, United States
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Norfolk, United States
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Spokane, United States
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Madison, United States
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Graz, Austria
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Krems, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Beijing, China
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Chengdu, China
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Guangzhou, China
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Angers, France
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Bordeaux, France
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Brest, France
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Calais, France
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Cedex 10, France
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Créteil, France
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Grenoble, France
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La Chaussée-Saint-Victor, France
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La Roche-sur-Yon, France
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Le Mans, France
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Lyon, France
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Marseille, France
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Marseille, France
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Montpellier, France
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Nantes, France
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Nîmes, France
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Paris, France
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Paris, France
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Pierre-Bénite, France
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Poitiers, France
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Quint-Fonsegrives, France
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Reims, France
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Saint-Etienne, France
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Saint-Herblain, France
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Strasbourg, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Eisleben Lutherstadt, Germany
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Herne, Germany
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Nürtingen, Germany
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Stuttgart, Germany
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Naples, Italy
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Roma, Italy
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Rozzano, Italy
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Bunkyō City, Japan
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Bunkyō City, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Hirosaki-shi, Japan
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Kanazawa, Japan
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Kawasaki, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Sapporo, Japan
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Shinjuku-ku, Japan
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Toyama, Japan
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Tsukuba, Japan
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Ube-shi, Japan
Trial contact
Contact for Trial Information
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.