RecruitingPhase 3NCT07419295

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

590 participants

Start Date

Apr 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Docetaxel, a drug called Paclitaxel, and others for people with bladder cancer. The study is currently recruiting participants at 67 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSacituzumab tirumotecan

IV infusion

DRUGVinflunine

IV infusion

DRUGDocetaxel

IV infusion

DRUGPaclitaxel

IV infusion

DRUGRescue medications for sacituzumab tirumotecan

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

DRUGRescue medications for chemotherapy

Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.


Locations(69)

Munson Medical Center ( Site 0812)

Traverse City, Michigan, United States

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)

Cincinnati, Ohio, United States

The West Clinic, P.C. ( Site 0791)

Germantown, Tennessee, United States

Thompson Cancer Survival Center ( Site 0803)

Knoxville, Tennessee, United States

Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 0002)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Oncologia de Rosario ( Site 0005)

Rosario, Santa Fe Province, Argentina

Macquarie University ( Site 0031)

Macquarie, New South Wales, Australia

Mater Hospital Brisbane ( Site 0032)

South Brisbane, Queensland, Australia

Cliniques Universitaires Saint-Luc ( Site 0062)

Brussels, Bruxelles-Capitale, Region de, Belgium

AZ Maria Middelares ( Site 0063)

Ghent, Oost-Vlaanderen, Belgium

UZ Gent ( Site 0064)

Ghent, Oost-Vlaanderen, Belgium

CHC Montlegia Clinic ( Site 0061)

Liège, Belgium

ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)

Curitiba, Paraná, Brazil

Hospital Moinhos de Vento ( Site 0102)

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)

São José do Rio Preto, São Paulo, Brazil

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)

Québec, Quebec, Canada

Peking University First Hospital ( Site 0184)

Beijing, Beijing Municipality, China

Sun Yat-Sen University Cancer Center ( Site 0183)

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center ( Site 0188)

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University ( Site 0205)

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)

Zhuhai, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)

Wuhan, Hubei, China

Fudan University Shanghai Cancer Center ( Site 0181)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University ( Site 0907)

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Ningbo University ( Site 0193)

Ningbo, Zhejiang, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)

Wenzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)

Wenzhou, Zhejiang, China

CHRU de Brest ( Site 0272)

Brest, Finistere, France

General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)

Athens, Attica, Greece

METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)

Athens, Attica, Greece

University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)

Chaïdári, Attica, Greece

Athens Medical Center ( Site 0336)

Marousi, Attica, Greece

Rambam Health Care Campus ( Site 0362)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0366)

Jerusalem, Israel

Rabin Medical Center ( Site 0364)

Petah Tikva, Israel

Sheba Medical Center ( Site 0361)

Ramat Gan, Israel

Yitzhak Shamir Medical Center. ( Site 0367)

Ẕerifin, Israel

Istituto Clinico Humanitas ( Site 0398)

Rozzano, Milano, Italy

Centro Ricerche Cliniche di Verona ( Site 0393)

Verona, Veneto, Italy

Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)

Arezzo, Italy

IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)

Genova, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)

Roma, Italy

Hokkaido University Hospital ( Site 0436)

Sapporo, Hokkaido, Japan

Kobe University Hospital ( Site 0431)

Kobe, Hyōgo, Japan

Kagawa University Hospital ( Site 0424)

Kita-gun, Kagawa-ken, Japan

St. Marianna University Hospital ( Site 0422)

Kawasaki, Kanagawa, Japan

Kitasato University Hospital ( Site 0425)

Sagamihara, Kanagawa, Japan

Nara Medical University Hospital ( Site 0423)

Kashihara, Nara, Japan

Osaka Rosai Hospital ( Site 0428)

Sakai, Osaka, Japan

Institute of Science Tokyo Hospital ( Site 0421)

Bunkyo, Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 0426)

Koto, Tokyo, Japan

Gifu University Hospital ( Site 0427)

Gifu, Japan

Maastricht UMC+ ( Site 0483)

Maastricht, Limburg, Netherlands

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)

Amsterdam, North Holland, Netherlands

Elisabeth-TweeSteden Ziekenhuis ( Site 0489)

Tilburg, North Holland, Netherlands

Isala, locatie Zwolle ( Site 0486)

Zwolle, Overijssel, Netherlands

St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)

Utrecht, Netherlands

H. de Badalona Germans Trias I Pujol ( Site 0603)

Badalona, Barcelona, Spain

Hospital Universitario Marques de Valdecilla ( Site 0605)

Santander, Cantabria, Spain

Hospital Universitario Insular de Gran Canaria ( Site 0604)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Ramon y Cajal ( Site 0606)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari Vall d'Hebron ( Site 0607)

Barcelona, Spain

Hospital Clinico San Carlos ( Site 0608)

Madrid, Spain

Hospital Universitario 12 de Octubre ( Site 0602)

Madrid, Spain

Hospital Virgen del Rocio ( Site 0601)

Seville, Spain

Laenssjukhuset Ryhov ( Site 0632)

Jönköping, Jönköping County, Sweden

Karolinska Universitetssjukhuset Solna ( Site 0631)

Stockholm, Stockholm County, Sweden

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