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New drug aims to outperform chemo in tough bladder cancer

NCT ID NCT07419295

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 19 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment * Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator * Has received treatment with anti-programmed cell death \[ligand\] 1 (anti-PD-\[L\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV) * Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry * Has received a maximum of 2 prior lines of therapy * Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine) * Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated * If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART) * If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load * If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load * Has adequate organ function Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy * Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) * Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC * Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine) * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy other than those permitted per protocol * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery, or has ongoing surgical complications

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    94 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)

    RECRUITING

    Berlin, 10117, Germany

  • Cliniques Universitaires Saint-Luc ( Site 0062)

    RECRUITING

    Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

  • Dana Farber Cancer Institute ( Site 0783)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Ehime University Hospital ( Site 0430)

    RECRUITING

    Tōon, Ehime, 791-0295, Japan

  • 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

  • Fred Hutchinson Cancer Research Center ( Site 0787)

    RECRUITING

    Seattle, Washington, 98109, United States

  • 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

  • Hirosaki University Hospital ( Site 0435)

    RECRUITING

    Hirosaki, Aomori, 036-8563, Japan

  • 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

  • Jiangsu Cancer Hospital ( Site 0917)

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Jiangxi Cancer Hospital ( Site 0192)

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Johns Hopkins University ( Site 0843)

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • 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

  • Morristown Memorial Hospital ( Site 0795)

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Munson Medical Center ( Site 0812)

    RECRUITING

    Traverse City, Michigan, 49684, United States

  • Nagoya University Hospital ( Site 0429)

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • 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

  • Sibley Memorial Hospital ( Site 0849)

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • St Bartholomew's Hospital ( Site 0751)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

  • 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 Second Xiangya Hospital of Central South University ( Site 0916)

    RECRUITING

    Changsha, Hunan, 410011, 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

  • West China Hospital of Sichuan University ( Site 0185)

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • 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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