Sacituzumab tirumotecan versus non‑platinum chemotherapy for advanced bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Hoag Memorial Hospital Presbyterian ( Site 0814)
  Newport Beach, California, United States Recruiting
• Sibley Memorial Hospital ( Site 0849)
  Washington D.C., District of Columbia, United States Recruiting
• Emory University Hospital ( Site 0824)
  Atlanta, Georgia, United States Recruiting
• Johns Hopkins University ( Site 0843)
  Baltimore, Maryland, United States Recruiting
• Dana Farber Cancer Institute ( Site 0783)
  Boston, Massachusetts, United States Recruiting
• Munson Medical Center ( Site 0812)
  Traverse City, Michigan, United States Recruiting

+63 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

  This study tests whether the combination of Sacituzumab Tirumotecan and Pembrolizumab can help people with advanced biliary tract cancer who have already had at least one approved therapy fail.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.