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RECRUITING Phase 3 ClinicalTrials.gov

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07419295

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Sacituzumab tirumotecan (Biological)
    IV infusion
  • Vinflunine (Drug)
    IV infusion
  • Docetaxel (Drug)
    IV infusion
  • Paclitaxel (Drug)
    IV infusion
  • Rescue medications for sacituzumab tirumotecan (Drug)
    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 (Drug)
    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.

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

Conditions

Bladder Cancer

Locations

  • Sibley Memorial Hospital ( Site 0849) — Washington D.C., District of Columbia, United States
  • Emory University Hospital ( Site 0824) — Atlanta, Georgia, United States
  • Johns Hopkins University ( Site 0843) — Baltimore, Maryland, United States
  • Dana Farber Cancer Institute ( Site 0783) — Boston, Massachusetts, United States
  • Munson Medical Center ( Site 0812) — Traverse City, Michigan, United States
  • Morristown Memorial Hospital ( Site 0795) — Morristown, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center ( Site 0832) — New York, New York, United States
  • WakeMed Raleigh Campus ( Site 0811) — Raleigh, North Carolina, United States
  • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822) — Cincinnati, Ohio, United States
  • University Hospitals of Cleveland Case Medical Center ( Site 0834) — Cleveland, Ohio, United States
  • Cleveland Clinic - Ohio ( Site 0793) — Cleveland, Ohio, United States
  • Fox Chase Cancer Center ( Site 0830) — Philadelphia, Pennsylvania, United States
  • The West Clinic, P.C. ( Site 0791) — Germantown, Tennessee, United States
  • Thompson Cancer Survival Center ( Site 0803) — Knoxville, Tennessee, United States
  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831) — Nashville, Tennessee, United States
  • Virginia Oncology Associates (VOA) ( Site 8002) — Norfolk, Virginia, United States
  • Fred Hutchinson Cancer Research Center ( Site 0787) — Seattle, Washington, United States
  • Hospital Italiano de Buenos Aires ( Site 0004) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
  • 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
  • Hospital Alemao Oswaldo Cruz ( Site 0101) — São Paulo, Brazil
  • Lakeridge Health ( Site 0122) — Oshawa, Ontario, Canada
  • Princess Margaret Cancer Centre ( Site 0123) — Toronto, Ontario, Canada
  • 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
  • The First Affiliated Hospital of Chonqing Medical University ( Site 0197) — Chongqing, Chongqing 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
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189) — 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
  • The Second Xiangya Hospital of Central South University ( Site 0916) — Changsha, Hunan, China
  • Jiangsu Cancer Hospital ( Site 0917) — Nanjing, Jiangsu, China
  • Jiangxi Cancer Hospital ( Site 0192) — Nanchang, Jiangxi, China
  • Fudan University Shanghai Cancer Center ( Site 0181) — Shanghai, Shanghai Municipality, China
  • Zhongshan Hospital Fudan University ( Site 0907) — Shanghai, Shanghai Municipality, China
  • West China Hospital of Sichuan University ( Site 0185) — Chengdu, Sichuan, China
  • The Second Hospital of Tianjin Medical University ( Site 0910) — Tianjin, Tianjin Municipality, China
  • The First Hospital of Jiaxing ( Site 0901) — Jiaxing, Zhejiang, 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
  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304) — Berlin, Germany
  • 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
  • European Interbalkan Medical Center ( Site 0331) — Thessaloniki, 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
  • Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391) — Orbassano, Piedmont, 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
  • Nagoya University Hospital ( Site 0429) — Nagoya, Aichi-ken, Japan
  • Hirosaki University Hospital ( Site 0435) — Hirosaki, Aomori, Japan
  • Ehime University Hospital ( Site 0430) — Tōon, Ehime, Japan
  • Hokkaido University Hospital ( Site 0436) — Sapporo, Hokkaido, Japan
  • Kobe University Hospital ( Site 0431) — Kobe, Hyōgo, Japan
  • University of Tsukuba Hospital ( Site 0432) — Tsukuba, Ibaraki, 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
  • Kyushu University Hospital ( Site 0434) — Fukuoka, Japan
  • Gifu University Hospital ( Site 0427) — Gifu, Japan
  • Kyoto University Hospital ( Site 0433) — Kyoto, Japan
  • Radboudumc ( Site 0487) — Nijmegen, Gelderland, Netherlands
  • 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
  • Erasmus Medisch Centrum ( Site 0481) — Rotterdam, South Holland, 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
  • Cambridge University Hospitals NHS Foundation Trust ( Site 0756) — Cambridge, Cambridgeshire, United Kingdom
  • St Bartholomew's Hospital ( Site 0751) — London, London, City of, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record