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NCT07419295PHASE3Recruiting

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

Merck Sharp & Dohme LLC

Start Date

4/23/2026

Completion Date

4/23/2030

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

DRUG

Vinflunine

DRUG

Docetaxel

DRUG

Paclitaxel

DRUG

Rescue medications for sacituzumab tirumotecan

DRUG

Rescue medications for chemotherapy

Interested in This Trial?

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Conditions

Bladder Cancer

Locations

Munson Medical Center ( Site 0812)

Traverse City, Michigan 49684

United States

TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)

Cincinnati, Ohio 45220

United States

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

Germantown, Tennessee 38138

United States

Thompson Cancer Survival Center ( Site 0803)

Knoxville, Tennessee 37916

United States

Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)

Ciudad Autonoma de Buenos Aires, Buenos Aires C1419AHN

Argentina

Instituto Alexander Fleming ( Site 0002)

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ

Argentina

Instituto de Oncologia de Rosario ( Site 0005)

Rosario, Santa Fe Province S2000KZE

Argentina

Macquarie University ( Site 0031)

Macquarie, New South Wales 2109

Australia

Mater Hospital Brisbane ( Site 0032)

South Brisbane, Queensland 4101

Australia

Cliniques Universitaires Saint-Luc ( Site 0062)

Brussels, Bruxelles-Capitale, Region de 1200

Belgium

AZ Maria Middelares ( Site 0063)

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Gent ( Site 0064)

Ghent, Oost-Vlaanderen 9000

Belgium

CHC Montlegia Clinic ( Site 0061)

Liège, 4000

Belgium

ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)

Curitiba, Paraná 80510-130

Brazil

Hospital Moinhos de Vento ( Site 0102)

Porto Alegre, Rio Grande do Sul 90560-032

Brazil

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

São José do Rio Preto, São Paulo 15090-000

Brazil

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

Québec, Quebec G1J 1Z4

Canada

Peking University First Hospital ( Site 0184)

Beijing, Beijing Municipality 100034

China

The First Affiliated Hospital of Chonqing Medical University ( Site 0197)

Chongqing, Chongqing Municipality 400010

China

Sun Yat-Sen University Cancer Center ( Site 0183)

Guangzhou, Guangdong 510060

China

Sun Yat-Sen University Cancer Center ( Site 0188)

Guangzhou, Guangdong 510060

China

Zhujiang Hospital of Southern Medical University ( Site 0205)

Guangzhou, Guangdong 510280

China

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

Zhuhai, Guangdong 519000

China

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

Wuhan, Hubei 430022

China

Fudan University Shanghai Cancer Center ( Site 0181)

Shanghai, Shanghai Municipality 200032

China

Zhongshan Hospital Fudan University ( Site 0907)

Shanghai, Shanghai Municipality 200032

China

The First Affiliated Hospital of Ningbo University ( Site 0193)

Ningbo, Zhejiang 315201

China

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

Wenzhou, Zhejiang 210008

China

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

Wenzhou, Zhejiang 325000

China

CHRU de Brest ( Site 0272)

Brest, Finistere 29200

France

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

Athens, Attica 145 64

Greece

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

Athens, Attica 155 62

Greece

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

Chaïdári, Attica 124 61

Greece

Athens Medical Center ( Site 0336)

Marousi, Attica 151 25

Greece

Rambam Health Care Campus ( Site 0362)

Haifa, 3109601

Israel

Shaare Zedek Medical Center ( Site 0366)

Jerusalem, 9103102

Israel

Rabin Medical Center ( Site 0364)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0361)

Ramat Gan, 5265601

Israel

Yitzhak Shamir Medical Center. ( Site 0367)

Ẕerifin, 7033001

Israel

Istituto Clinico Humanitas ( Site 0398)

Rozzano, Milano 20089

Italy

Centro Ricerche Cliniche di Verona ( Site 0393)

Verona, Veneto 37134

Italy

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

Arezzo, 52100

Italy

IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)

Genova, 16132

Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)

Milan, 20133

Italy

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

Roma, 00168

Italy

Hokkaido University Hospital ( Site 0436)

Sapporo, Hokkaido 060-8648

Japan

Kobe University Hospital ( Site 0431)

Kobe, Hyōgo 650-0017

Japan

Kagawa University Hospital ( Site 0424)

Kita-gun, Kagawa-ken 761-0793

Japan

St. Marianna University Hospital ( Site 0422)

Kawasaki, Kanagawa 216-8511

Japan

Kitasato University Hospital ( Site 0425)

Sagamihara, Kanagawa 252-0375

Japan

Nara Medical University Hospital ( Site 0423)

Kashihara, Nara 634-8522

Japan

Osaka Rosai Hospital ( Site 0428)

Sakai, Osaka 591-8025

Japan

Institute of Science Tokyo Hospital ( Site 0421)

Bunkyo, Tokyo 113-8519

Japan

Cancer Institute Hospital of JFCR ( Site 0426)

Koto, Tokyo 135-8550

Japan

Gifu University Hospital ( Site 0427)

Gifu, 501-1194

Japan

Maastricht UMC+ ( Site 0483)

Maastricht, Limburg 6229 HX

Netherlands

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

Amsterdam, North Holland 1066 CX

Netherlands

Elisabeth-TweeSteden Ziekenhuis ( Site 0489)

Tilburg, North Holland 5022 GC

Netherlands

Isala, locatie Zwolle ( Site 0486)

Zwolle, Overijssel 8025 AB

Netherlands

St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)

Utrecht, 3543 AZ

Netherlands

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

Badalona, Barcelona 08916

Spain

Hospital Universitario Marques de Valdecilla ( Site 0605)

Santander, Cantabria 39008

Spain

Hospital Universitario Insular de Gran Canaria ( Site 0604)

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

Hospital Universitario Ramon y Cajal ( Site 0606)

Madrid, Madrid, Comunidad de 28034

Spain

Hospital Universitari Vall d'Hebron ( Site 0607)

Barcelona, 08035

Spain

Hospital Clinico San Carlos ( Site 0608)

Madrid, 28040

Spain

Hospital Universitario 12 de Octubre ( Site 0602)

Madrid, 28041

Spain

Hospital Virgen del Rocio ( Site 0601)

Seville, 41013

Spain

Laenssjukhuset Ryhov ( Site 0632)

Jönköping, Jönköping County 551 85

Sweden

Karolinska Universitetssjukhuset Solna ( Site 0631)

Stockholm, Stockholm County 171 76

Sweden

Cambridge University Hospitals NHS Foundation Trust ( Site 0756)

Cambridge, Cambridgeshire CB2 0QQ

United Kingdom