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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
590
Start Date
2026-04-23
Completion Date
2030-04-23
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
IV infusion
Vinflunine
IV infusion
Docetaxel
IV infusion
Paclitaxel
IV infusion
Rescue 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).
Rescue 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 (42)
Munson Medical Center ( Site 0812)
Traverse City, Michigan, United States
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
Cincinnati, Ohio, 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
Macquarie University ( Site 0031)
Macquarie, New South Wales, Australia
AZ Maria Middelares ( Site 0063)
Ghent, Oost-Vlaanderen, Belgium
UZ Gent ( Site 0064)
Ghent, Oost-Vlaanderen, Belgium
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
São José do Rio Preto, São Paulo, Brazil
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
General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
Athens, 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
Centro Ricerche Cliniche di Verona ( Site 0393)
Verona, Veneto, Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
Milan, Italy
Kagawa University Hospital ( Site 0424)
Kita-gun, Kagawa-ken, Japan
St. Marianna University Hospital ( Site 0422)
Kawasaki, Kanagawa, Japan
Osaka Rosai Hospital ( Site 0428)
Sakai, Osaka, Japan
Institute of Science Tokyo Hospital ( Site 0421)
Bunkyo, Tokyo, Japan
Isala, locatie Zwolle ( Site 0486)
Zwolle, Overijssel, 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
Karolinska Universitetssjukhuset Solna ( Site 0631)
Stockholm, Stockholm County, Sweden