Boosting Treatment Options for Advanced Bladder Cancer with New Medicine
NCT07419295 · RecruitingThis trial studies a new medicine called sacituzumab tirumotecan (Sac-TMT) for people with locally advanced or metastatic urothelial cancer, also known as bladder cancer. Researchers want to see if Sac-TMT can help patients live longer compared to other non-platinum chemotherapy options. Current treatments include chemotherapy, immunotherapy, and targeted therapy, but this trial looks for better ways to treat this type of cancer after other treatments have not worked as well.
Locations and contact
This trial is running at 65 locations in 15 countries. All of them are currently recruiting.
United States4 locations · 4 recruiting
- Munson Medical Center ( Site 0812)Traverse City, MichiganRecruiting
- The West Clinic, P.C. ( Site 0791)Germantown, TennesseeRecruiting
- Thompson Cancer Survival Center ( Site 0803)Knoxville, TennesseeRecruiting
- TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)Cincinnati, OhioRecruiting
China11 locations · 11 recruiting
- Fudan University Shanghai Cancer Center ( Site 0181)Shanghai, Shanghai MunicipalityRecruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)Wenzhou, ZhejiangRecruiting
- Peking University First Hospital ( Site 0184)Beijing, Beijing MunicipalityRecruiting
- Sun Yat-Sen University Cancer Center ( Site 0183)Guangzhou, GuangdongRecruiting
- Sun Yat-Sen University Cancer Center ( Site 0188)Guangzhou, GuangdongRecruiting
- The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)Zhuhai, GuangdongRecruiting
- The First Affiliated Hospital of Ningbo University ( Site 0193)Ningbo, ZhejiangRecruiting
- The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)Wenzhou, ZhejiangRecruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)Wuhan, HubeiRecruiting
- Zhongshan Hospital Fudan University ( Site 0907)Shanghai, Shanghai MunicipalityRecruiting
- Zhujiang Hospital of Southern Medical University ( Site 0205)Guangzhou, GuangdongRecruiting
Japan8 locations · 8 recruiting
- Gifu University Hospital ( Site 0427)GifuRecruiting
- Hokkaido University Hospital ( Site 0436)Sapporo, HokkaidoRecruiting
- Institute of Science Tokyo Hospital ( Site 0421)Bunkyo, TokyoRecruiting
- Kagawa University Hospital ( Site 0424)Kita-gun, Kagawa-kenRecruiting
- Kobe University Hospital ( Site 0431)Kobe, HyōgoRecruiting
- Nara Medical University Hospital ( Site 0423)Kashihara, NaraRecruiting
- Osaka Rosai Hospital ( Site 0428)Sakai, OsakaRecruiting
- St. Marianna University Hospital ( Site 0422)Kawasaki, KanagawaRecruiting
Spain8 locations · 8 recruiting
- H. de Badalona Germans Trias I Pujol ( Site 0603)Badalona, BarcelonaRecruiting
- Hospital Clinico San Carlos ( Site 0608)MadridRecruiting
- Hospital Universitari Vall d'Hebron ( Site 0607)BarcelonaRecruiting
- Hospital Universitario 12 de Octubre ( Site 0602)MadridRecruiting
- Hospital Universitario Insular de Gran Canaria ( Site 0604)Las Palmas de Gran Canaria, Las PalmasRecruiting
- Hospital Universitario Marques de Valdecilla ( Site 0605)Santander, CantabriaRecruiting
- Hospital Universitario Ramon y Cajal ( Site 0606)Madrid, Madrid, Comunidad deRecruiting
- Hospital Virgen del Rocio ( Site 0601)SevilleRecruiting
Italy6 locations · 6 recruiting
- Centro Ricerche Cliniche di Verona ( Site 0393)Verona, VenetoRecruiting
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)MilanRecruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)RomaRecruiting
- IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)GenovaRecruiting
- Istituto Clinico Humanitas ( Site 0398)Rozzano, MilanoRecruiting
- Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)ArezzoRecruiting
Israel5 locations · 5 recruiting
- Rabin Medical Center ( Site 0364)Petah TikvaRecruiting
- Rambam Health Care Campus ( Site 0362)HaifaRecruiting
- Shaare Zedek Medical Center ( Site 0366)JerusalemRecruiting
- Sheba Medical Center ( Site 0361)Ramat GanRecruiting
- Yitzhak Shamir Medical Center. ( Site 0367)ẔerifinRecruiting
Greece4 locations · 4 recruiting
- Athens Medical Center ( Site 0336)Marousi, AtticaRecruiting
- General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)Athens, AtticaRecruiting
- METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)Athens, AtticaRecruiting
- University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)Chaïdári, AtticaRecruiting
Netherlands4 locations · 4 recruiting
- Elisabeth-TweeSteden Ziekenhuis ( Site 0489)Tilburg, North HollandRecruiting
- Isala, locatie Zwolle ( Site 0486)Zwolle, OverijsselRecruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)Amsterdam, North HollandRecruiting
- St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)UtrechtRecruiting
Argentina3 locations · 3 recruiting
- Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)Ciudad Autonoma de Buenos Aires, Buenos AiresRecruiting
- Instituto Alexander Fleming ( Site 0002)Ciudad Autónoma de Buenos Aires, Buenos AiresRecruiting
- Instituto de Oncologia de Rosario ( Site 0005)Rosario, Santa Fe ProvinceRecruiting
Belgium3 locations · 3 recruiting
- AZ Maria Middelares ( Site 0063)Ghent, Oost-VlaanderenRecruiting
- CHC Montlegia Clinic ( Site 0061)LiègeRecruiting
- UZ Gent ( Site 0064)Ghent, Oost-VlaanderenRecruiting
Brazil3 locations · 3 recruiting
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)São José do Rio Preto, São PauloRecruiting
- Hospital Moinhos de Vento ( Site 0102)Porto Alegre, Rio Grande do SulRecruiting
- ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)Curitiba, ParanáRecruiting
Australia2 locations · 2 recruiting
- Macquarie University ( Site 0031)Macquarie, New South WalesRecruiting
- Mater Hospital Brisbane ( Site 0032)South Brisbane, QueenslandRecruiting
Sweden2 locations · 2 recruiting
- Karolinska Universitetssjukhuset Solna ( Site 0631)Stockholm, Stockholm CountyRecruiting
- Laenssjukhuset Ryhov ( Site 0632)Jönköping, Jönköping CountyRecruiting
Canada1 location · 1 recruiting
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)Québec, QuebecRecruiting
France1 location · 1 recruiting
- CHRU de Brest ( Site 0272)Brest, FinistereRecruiting
Who can join
Adults aged 18 and older, both men and women, can join this trial. Participants must have advanced bladder cancer that has not improved after previous treatments. They should have received specific therapies and have certain health conditions. The trial team will check to make sure everyone meets the criteria to participate.
What happens during the trial
Participants will be randomly placed into two groups. One group will receive sacituzumab tirumotecan through an IV every two weeks. The other group will receive a choice of chemotherapy drugs like paclitaxel, docetaxel, or vinflunine every three weeks. Everyone will continue treatment until their cancer progresses or they experience unacceptable side effects.
The trial team
The trial is sponsored by Merck Sharp & Dohme LLC. The lead doctor overseeing the study is a Medical Director from Merck Sharp & Dohme LLC.
Important dates
The trial started on April 23, 2026, and is currently enrolling participants. It is expected to be completed by April 23, 2030, with the primary completion date around July 27, 2029.
Additional information
This study is identified by NCT07419295. It is a Phase 3 trial, which means it is testing how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 590 participants.
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