A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma
- Bladder Cancer
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 590
- Started
- 23 April 2026
- Main results due
- 27 July 2029
- Study sites
- 95
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.
Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.
Study sites(95)
Sibley Memorial Hospital ( Site 0849)
Washington D.C., District of Columbia, United States
Recruiting
Johns Hopkins University ( Site 0843)
Baltimore, Maryland, United States
Recruiting
Dana Farber Cancer Institute ( Site 0783)
Boston, Massachusetts, United States
Recruiting
Munson Medical Center ( Site 0812)
Traverse City, Michigan, United States
Recruiting
Morristown Memorial Hospital ( Site 0795)
Morristown, New Jersey, United States
Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0832)
New York, New York, United States
Recruiting
WakeMed Raleigh Campus ( Site 0811)
Raleigh, North Carolina, United States
Recruiting
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, United States
Recruiting
The West Clinic, P.C. ( Site 0791)
Germantown, Tennessee, United States
Recruiting
Thompson Cancer Survival Center ( Site 0803)
Knoxville, Tennessee, United States
Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)
Nashville, Tennessee, United States
Recruiting
Virginia Oncology Associates (VOA) ( Site 8002)
Norfolk, Virginia, United States
Recruiting
Fred Hutchinson Cancer Research Center ( Site 0787)
Seattle, Washington, United States
Recruiting
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming ( Site 0002)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto de Oncologia de Rosario ( Site 0005)
Rosario, Santa Fe Province, Argentina
Recruiting
Macquarie University ( Site 0031)
Macquarie, New South Wales, Australia
Recruiting
Mater Hospital Brisbane ( Site 0032)
South Brisbane, Queensland, Australia
Recruiting
Cliniques Universitaires Saint-Luc ( Site 0062)
Brussels, Bruxelles-Capitale, Region de, Belgium
Recruiting
AZ Maria Middelares ( Site 0063)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
UZ Gent ( Site 0064)
Ghent, Oost-Vlaanderen, Belgium
Recruiting
CHC Montlegia Clinic ( Site 0061)
Liège, Belgium
Recruiting
ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)
Curitiba, Paraná, Brazil
Recruiting
Hospital Moinhos de Vento ( Site 0102)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
São José do Rio Preto, São Paulo, Brazil
Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)
Québec, Quebec, Canada
Recruiting
Peking University First Hospital ( Site 0184)
Beijing, Beijing Municipality, China
Recruiting
The First Affiliated Hospital of Chonqing Medical University ( Site 0197)
Chongqing, Chongqing Municipality, China
Recruiting
Sun Yat-Sen University Cancer Center ( Site 0183)
Guangzhou, Guangdong, China
Recruiting
Sun Yat-Sen University Cancer Center ( Site 0188)
Guangzhou, Guangdong, China
Recruiting
Zhujiang Hospital of Southern Medical University ( Site 0205)
Guangzhou, Guangdong, China
Recruiting
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
Zhuhai, Guangdong, China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
Wuhan, Hubei, China
Recruiting
The Second Xiangya Hospital of Central South University ( Site 0916)
Changsha, Hunan, China
Recruiting
Jiangsu Cancer Hospital ( Site 0917)
Nanjing, Jiangsu, China
Recruiting
Jiangxi Cancer Hospital ( Site 0192)
Nanchang, Jiangxi, China
Recruiting
Fudan University Shanghai Cancer Center ( Site 0181)
Shanghai, Shanghai Municipality, China
Recruiting
Zhongshan Hospital Fudan University ( Site 0907)
Shanghai, Shanghai Municipality, China
Recruiting
West China Hospital of Sichuan University ( Site 0185)
Chengdu, Sichuan, China
Recruiting
The Second Hospital of Tianjin Medical University ( Site 0910)
Tianjin, Tianjin Municipality, China
Recruiting
The First Hospital of Jiaxing ( Site 0901)
Jiaxing, Zhejiang, China
Recruiting
The First Affiliated Hospital of Ningbo University ( Site 0193)
Ningbo, Zhejiang, China
Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
Wenzhou, Zhejiang, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
Wenzhou, Zhejiang, China
Recruiting
CHRU de Brest ( Site 0272)
Brest, Finistere, France
Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)
Berlin, Germany
Recruiting
General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
Athens, Attica, Greece
Recruiting
METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)
Athens, Attica, Greece
Recruiting
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)
Chaïdári, Attica, Greece
Recruiting
Athens Medical Center ( Site 0336)
Marousi, Attica, Greece
Recruiting
Rambam Health Care Campus ( Site 0362)
Haifa, Israel
Recruiting
Shaare Zedek Medical Center ( Site 0366)
Jerusalem, Israel
Recruiting
Rabin Medical Center ( Site 0364)
Petah Tikva, Israel
Recruiting
Sheba Medical Center ( Site 0361)
Ramat Gan, Israel
Recruiting
Yitzhak Shamir Medical Center. ( Site 0367)
Ẕerifin, Israel
Recruiting
Istituto Clinico Humanitas ( Site 0398)
Rozzano, Milano, Italy
Recruiting
Centro Ricerche Cliniche di Verona ( Site 0393)
Verona, Veneto, Italy
Recruiting
Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
Arezzo, Italy
Recruiting
IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)
Genova, Italy
Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
Milan, Italy
Recruiting
Showing 60 of 95 sites — filter to narrow it down. 95 of the 95 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07419295. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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