Sacituzumab Tirumotecan for Urothelial Cancer
This study is looking for better ways to treat locally advanced or metastatic urothelial cancer (bladder cancer) that has worsened after previous treatments. Researchers want to see if a medicine called sacituzumab tirumotecan (Sac-TMT) helps people live longer compared to standard chemotherapy medicines like vinflunine, docetaxel, or paclitaxel. Sacituzumab tirumotecan works as both an immunotherapy and a targeted therapy. You might be able to join if you are 18 or older, have locally advanced or metastatic urothelial cancer that cannot be removed by surgery or radiation, and your cancer can be measured. The study aims to enroll 590 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing sacituzumab tirumotecan to standard chemotherapy options. It plans to enroll 590 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival for up to approximately 40 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07419295
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Recruiting
PHASE3Ages 18+InterventionalTreatmentMerck Sharp & Dohme LLC
~590 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanVinflunineDocetaxelPaclitaxelRescue medications for sacituzumab tirumotecanRescue medications for chemotherapy
At a glance
Recruiting sites
86 of 86 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 40 months
Conditions
Where it's being run
86 sites across 58 statesIsrael5
Guangdong4
Zhejiang4
Attica4
Italy4
Spain4
Japan3
Tennessee2
Study leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Overall Survival (OS)Up to approximately 40 months
OS is defined as time from randomization to death due to any cause.