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Clinical Trials in the UK / NCT07419295
Recruiting Phase 3

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

NCT07419295 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-04-23
Last updated
2026-09-11

Condition(s) studied

Bladder Cancer

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecanVinflunineDocetaxelPaclitaxelRescue medications for sacituzumab tirumotecanRescue medications for chemotherapy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Sibley Memorial Hospital ( Site 0849) Washington D.C. District of Columbia Recruiting
Johns Hopkins University ( Site 0843) Baltimore Maryland Recruiting
Munson Medical Center ( Site 0812) Traverse City Michigan Recruiting
Morristown Memorial Hospital ( Site 0795) Morristown New Jersey Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0832) New York New York Recruiting
WakeMed Raleigh Campus ( Site 0811) Raleigh North Carolina Recruiting
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822) Cincinnati Ohio Recruiting
The West Clinic, P.C. ( Site 0791) Germantown Tennessee Recruiting
Thompson Cancer Survival Center ( Site 0803) Knoxville Tennessee Recruiting
Virginia Oncology Associates (VOA) ( Site 8002) Norfolk Virginia Recruiting
Fred Hutchinson Cancer Research Center ( Site 0787) Seattle Washington Recruiting
Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003) Ciudad Autonoma de Buenos Aires Buenos Aires Recruiting
Instituto Alexander Fleming ( Site 0002) Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto de Oncologia de Rosario ( Site 0005) Rosario Santa Fe Province Recruiting
Macquarie University ( Site 0031) Macquarie New South Wales Recruiting
Mater Hospital Brisbane ( Site 0032) South Brisbane Queensland Recruiting
Cliniques Universitaires Saint-Luc ( Site 0062) Brussels Bruxelles-Capitale, Region de Recruiting
AZ Maria Middelares ( Site 0063) Ghent Oost-Vlaanderen Recruiting
UZ Gent ( Site 0064) Ghent Oost-Vlaanderen Recruiting
CHC Montlegia Clinic ( Site 0061) Liège Belgium Recruiting
ICTRIALS Pesquisa e Desenvolvimento ( Site 0107) Curitiba Paraná Recruiting
Hospital Moinhos de Vento ( Site 0102) Porto Alegre Rio Grande do Sul Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110) São José do Rio Preto São Paulo Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121) Québec Quebec Recruiting
Peking University First Hospital ( Site 0184) Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chonqing Medical University ( Site 0197) Chongqing Chongqing Municipality Recruiting
Sun Yat-Sen University Cancer Center ( Site 0183) Guangzhou Guangdong Recruiting
Sun Yat-Sen University Cancer Center ( Site 0188) Guangzhou Guangdong Recruiting
Zhujiang Hospital of Southern Medical University ( Site 0205) Guangzhou Guangdong Recruiting
The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900) Zhuhai Guangdong Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198) Wuhan Hubei Recruiting
The Second Xiangya Hospital of Central South University ( Site 0916) Changsha Hunan Recruiting
Jiangsu Cancer Hospital ( Site 0917) Nanjing Jiangsu Recruiting
Fudan University Shanghai Cancer Center ( Site 0181) Shanghai Shanghai Municipality Recruiting
Zhongshan Hospital Fudan University ( Site 0907) Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University ( Site 0185) Chengdu Sichuan Recruiting
The Second Hospital of Tianjin Medical University ( Site 0910) Tianjin Tianjin Municipality Recruiting
The First Hospital of Jiaxing ( Site 0901) Jiaxing Zhejiang Recruiting
The First Affiliated Hospital of Ningbo University ( Site 0193) Ningbo Zhejiang Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186) Wenzhou Zhejiang Recruiting

+ 51 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07419295 on ClinicalTrials.gov ↗ ← All trials in the UK