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RECRUITING

NCT07419295

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

2026-07-10

Healthy Volunteers

Conditions

Bladder Cancer

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

IV infusion

DRUG

Vinflunine

IV infusion

DRUG

Docetaxel

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

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).

DRUG

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.

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

Locations (67)

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

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (67)