Sacituzumab Tirumotecan for Bladder Cancer

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

Recruiting Phase 3 Interventional Study
Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
590 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with bladder cancer that has spread or got worse after previous treatments. Participants will receive a new treatment called sacituzumab tirumotecan and be compared to those receiving standard chemotherapy options.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have locally advanced or metastatic bladder cancer
  • I have measurable disease as confirmed by my doctor
  • I have been treated with anti-PD-L1 therapy and platinum-based chemotherapy
  • I have received no more than 2 prior lines of therapy
  • I have disease progression after my last treatment
  • I have an ECOG performance status of 0 or 1
  • I can provide a tissue sample or tumor biopsy
  • I have well-controlled HIV or hepatitis B/C

You may not be able to join if

  • I have severe dry eye syndrome or corneal disease
  • I have uncontrolled significant heart or brain disease
  • I have a history of interstitial lung disease or pneumonitis
  • I have received anticancer therapy in the last 4 weeks
  • I have had previous treatment with a TROP2-targeted therapy
  • I have had radiation therapy recently or have radiation-related side effects
  • I have had a major surgery recently or have surgical complications
  • I have an active infection requiring systemic therapy

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 goa…
Trial Locations
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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 * Ha…
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