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Sacituzumab tirumotecan versus non‑platinum chemotherapy for advanced bladder cancer

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT07419295

This trial will test whether sacituzumab tirumotecan can help people with advanced urothelial (bladder) cancer live longer than certain non‑platinum chemotherapies after their disease worsens following prior treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment590 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsenfortumab, disitamab, chemotherapy, radiation, sacituzumab, immunotherapy
Locations27 sites (Cincinnati, Ohio and 26 other locations)
Trial IDNCT07419295 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial enrolls people with locally advanced or metastatic urothelial cancer that has measurable disease and progressed after prior PD-(L)1 therapy, platinum-based chemotherapy, and enfortumab vedotin. Eligible participants are randomized to receive sacituzumab tirumotecan or one of several non‑platinum chemotherapies (vinflunine, docetaxel, or paclitaxel) with supportive/rescue medications as needed. The primary goal is to compare overall survival between the sacituzumab tirumotecan arm and the non‑platinum chemotherapy arm. The study allows up to three prior lines of therapy and includes site-specific exceptions for disitamab vedotin in China.

Who should consider this trial

Good fit: People with histologically confirmed locally advanced or metastatic urothelial cancer with measurable disease who have progressed after prior PD-(L)1 therapy, platinum‑based chemotherapy, and enfortumab vedotin, and who have had no more than three prior lines of therapy are the intended candidates.

Not a fit: Patients whose cancer is still amenable to curative surgery or radiation, who have received more than three prior lines of therapy, or who have not received the required prior treatments (except the China-specific disitamab vedotin allowance) are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, sacituzumab tirumotecan could extend survival compared with non‑platinum chemotherapy for patients with advanced urothelial cancer who have progressed after standard prior therapies.

How similar studies have performed: Antibody–drug conjugates and Trop-2–targeting agents have shown activity in urothelial cancer in earlier trials, but this Phase 3 comparison of sacituzumab tirumotecan to non‑platinum chemotherapy is a later-stage test of that approach.

Eligibility criteria

Show full inclusion / exclusion 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
* 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 3 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) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* 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

Where this trial is running

Cincinnati, Ohio and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bladder Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.