New drug aims to outperform chemo in tough bladder cancer

NCT ID NCT07419295

Recruiting now Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 11 times

Summary

This phase 3 trial tests whether the experimental drug sacituzumab tirumotecan helps people with advanced bladder cancer live longer than standard chemotherapy. About 590 participants whose cancer worsened after prior treatments will receive either the new drug or one of several chemotherapies. The study compares overall survival and tumor progression between the two groups.

What this could mean

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

Active substance: sacituzumab tirumotecan (a targeted antibody-drug conjugate)
What this could lead to: If it works, this could offer a new treatment option for people with advanced bladder cancer that has stopped responding to other therapies.
What could go wrong: This is an early-phase 3 trial, so results are not yet known. The experimental drug may not work better than standard chemotherapy and could cause side effects like low blood cell counts or allergic reactions.

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

BLADDER CANCER

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

AZ Maria Middelares ( Site 0063)
RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
RECRUITING

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN, Argentina
Athens Medical Center ( Site 0336)
RECRUITING

Marousi, Attica, 151 25, Greece
CHC Montlegia Clinic ( Site 0061)
RECRUITING

Liège, 4000, Belgium
CHRU de Brest ( Site 0272)
RECRUITING

Brest, Finistere, 29200, France
Cambridge University Hospitals NHS Foundation Trust ( Site 0756)
RECRUITING

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Cancer Institute Hospital of JFCR ( Site 0426)
RECRUITING

Koto, Tokyo, 135-8550, Japan
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)
RECRUITING

Québec, Quebec, G1J 1Z4, Canada
Centro Ricerche Cliniche di Verona ( Site 0393)
RECRUITING

Verona, Veneto, 37134, Italy
Cliniques Universitaires Saint-Luc ( Site 0062)
RECRUITING

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
Elisabeth-TweeSteden Ziekenhuis ( Site 0489)
RECRUITING

Tilburg, North Holland, 5022 GC, Netherlands
Erasmus Medisch Centrum ( Site 0481)
RECRUITING

Rotterdam, South Holland, 3015 GD, Netherlands
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)
RECRUITING

Roma, 00168, Italy
Fudan University Shanghai Cancer Center ( Site 0181)
RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
RECRUITING

São José do Rio Preto, São Paulo, 15090-000, Brazil
General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
RECRUITING

Athens, Attica, 145 64, Greece
Gifu University Hospital ( Site 0427)
RECRUITING

Gifu, 501-1194, Japan
H. de Badalona Germans Trias I Pujol ( Site 0603)
RECRUITING

Badalona, Barcelona, 08916, Spain
Hokkaido University Hospital ( Site 0436)
RECRUITING

Sapporo, Hokkaido, 060-8648, Japan
Hospital Clinico San Carlos ( Site 0608)
RECRUITING

Madrid, 28040, Spain
Hospital Moinhos de Vento ( Site 0102)
RECRUITING

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Hospital Universitari Vall d'Hebron ( Site 0607)
RECRUITING

Barcelona, 08035, Spain
Hospital Universitario 12 de Octubre ( Site 0602)
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Insular de Gran Canaria ( Site 0604)
RECRUITING

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Marques de Valdecilla ( Site 0605)
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Ramon y Cajal ( Site 0606)
RECRUITING

Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Virgen del Rocio ( Site 0601)
RECRUITING

Seville, 41013, Spain
ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)
RECRUITING

Curitiba, Paraná, 80510-130, Brazil
IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)
RECRUITING

Genova, 16132, Italy
Institute of Science Tokyo Hospital ( Site 0421)
RECRUITING

Bunkyo, Tokyo, 113-8519, Japan
Instituto Alexander Fleming ( Site 0002)
RECRUITING

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Instituto de Oncologia de Rosario ( Site 0005)
RECRUITING

Rosario, Santa Fe Province, S2000KZE, Argentina
Isala, locatie Zwolle ( Site 0486)
RECRUITING

Zwolle, Overijssel, 8025 AB, Netherlands
Istituto Clinico Humanitas ( Site 0398)
RECRUITING

Rozzano, Milano, 20089, Italy
Kagawa University Hospital ( Site 0424)
RECRUITING

Kita-gun, Kagawa-ken, 761-0793, Japan
Karolinska Universitetssjukhuset Solna ( Site 0631)
RECRUITING

Stockholm, Stockholm County, 171 76, Sweden
Kitasato University Hospital ( Site 0425)
RECRUITING

Sagamihara, Kanagawa, 252-0375, Japan
Kobe University Hospital ( Site 0431)
RECRUITING

Kobe, Hyōgo, 650-0017, Japan
Kyoto University Hospital ( Site 0433)
RECRUITING

Kyoto, 606-8507, Japan
Kyushu University Hospital ( Site 0434)
RECRUITING

Fukuoka, 812-8582, Japan
Laenssjukhuset Ryhov ( Site 0632)
RECRUITING

Jönköping, Jönköping County, 551 85, Sweden
METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)
RECRUITING

Athens, Attica, 155 62, Greece
Maastricht UMC+ ( Site 0483)
RECRUITING

Maastricht, Limburg, 6229 HX, Netherlands
Macquarie University ( Site 0031)
RECRUITING

Macquarie, New South Wales, 2109, Australia
Mater Hospital Brisbane ( Site 0032)
RECRUITING

South Brisbane, Queensland, 4101, Australia
Memorial Sloan Kettering Cancer Center ( Site 0832)
RECRUITING

New York, New York, 10065, United States
Munson Medical Center ( Site 0812)
RECRUITING

Traverse City, Michigan, 49684, United States
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
RECRUITING

Wenzhou, Zhejiang, 210008, China
Nara Medical University Hospital ( Site 0423)
RECRUITING

Kashihara, Nara, 634-8522, Japan
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)
RECRUITING

Amsterdam, North Holland, 1066 CX, Netherlands
Osaka Rosai Hospital ( Site 0428)
RECRUITING

Sakai, Osaka, 591-8025, Japan
Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
RECRUITING

Arezzo, 52100, Italy
Peking University First Hospital ( Site 0184)
RECRUITING

Beijing, Beijing Municipality, 100034, China
Rabin Medical Center ( Site 0364)
RECRUITING

Petah Tikva, 4941492, Israel
Rambam Health Care Campus ( Site 0362)
RECRUITING

Haifa, 3109601, Israel
Shaare Zedek Medical Center ( Site 0366)
RECRUITING

Jerusalem, 9103102, Israel
Sheba Medical Center ( Site 0361)
RECRUITING

Ramat Gan, 5265601, Israel
St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)
RECRUITING

Utrecht, 3543 AZ, Netherlands
St. Marianna University Hospital ( Site 0422)
RECRUITING

Kawasaki, Kanagawa, 216-8511, Japan
Sun Yat-Sen University Cancer Center ( Site 0183)
RECRUITING

Guangzhou, Guangdong, 510060, China
Sun Yat-Sen University Cancer Center ( Site 0188)
RECRUITING

Guangzhou, Guangdong, 510060, China
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
RECRUITING

Zhuhai, Guangdong, 519000, China
The First Affiliated Hospital of Chonqing Medical University ( Site 0197)
RECRUITING

Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Ningbo University ( Site 0193)
RECRUITING

Ningbo, Zhejiang, 315201, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
RECRUITING

Wenzhou, Zhejiang, 325000, China
The First Hospital of Jiaxing ( Site 0901)
RECRUITING

Jiaxing, Zhejiang, 314033, China
The Second Hospital of Tianjin Medical University ( Site 0910)
RECRUITING

Tianjin, Tianjin Municipality, 300211, China
The West Clinic, P.C. ( Site 0791)
RECRUITING

Germantown, Tennessee, 38138, United States
Thompson Cancer Survival Center ( Site 0803)
RECRUITING

Knoxville, Tennessee, 37916, United States
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
RECRUITING

Cincinnati, Ohio, 45220, United States
UZ Gent ( Site 0064)
RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
RECRUITING

Wuhan, Hubei, 430022, China
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)
RECRUITING

Chaïdári, Attica, 124 61, Greece
University of Tsukuba Hospital ( Site 0432)
RECRUITING

Tsukuba, Ibaraki, 305-8576, Japan
Virginia Oncology Associates (VOA) ( Site 8002)
RECRUITING

Norfolk, Virginia, 23502, United States
WakeMed Raleigh Campus ( Site 0811)
RECRUITING

Raleigh, North Carolina, 27610, United States
Yitzhak Shamir Medical Center. ( Site 0367)
RECRUITING

Ẕerifin, 7033001, Israel
Zhongshan Hospital Fudan University ( Site 0907)
RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Zhujiang Hospital of Southern Medical University ( Site 0205)
RECRUITING

Guangzhou, Guangdong, 510280, China

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