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A study of sacituzumab tirumotecan versus docetaxel, paclitaxel, or vinflunine for patients with pretreated advanced or metastatic bladder cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Locally Advanced/Metastatic Urothelial Carcinoma, which is a type of cancer that starts in the lining of the urinary tract and has either grown into nearby tissues or spread to other parts of the body. The purpose of the study is to compare the effectiveness of a new medication called MK-2870, also known as sacituzumab tirumotecan, against other available chemotherapy treatments that do not contain platinum.

Participants in the study may receive MK-2870 through an intravenous infusion, which is a method of delivering medicine directly into a vein. Other participants will receive a choice of different chemotherapy drugs selected by the doctor, such as docetaxel, vinflunine, or paclitaxel. Some participants may also be given colony stimulating factors, which are substances used to help the body produce more white blood cells, or corticosteroids, which are medicines used to reduce swelling or inflammation.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Assignment to a treatment group

    You will be assigned to one of two groups to receive a specific type of intravenous infusion, which is a method of delivering medication directly into a vein.

  2. Step 2

    Receiving test medication

    If assigned to the test group, you will receive sacituzumab tirumotecan. the dose is 4 mg/kg, which means 4 milligrams of the medicine for every kilogram of your body weight, administered through an intravenous infusion.

  3. Step 3

    Receiving comparator medication

    If assigned to the comparator group, you will receive a type of non-platinum chemotherapy chosen by the investigator. this may include docetaxel at a dose of 75 mg/m2 (milligrams per square meter of body surface area), vinflunine at a dose of 320 mg/m2, or paclitaxel at a dose of 175 mg/m2, all delivered via intravenous infusion.

Who can join the trial?

13 criteria

  • You must have urothelial carcinoma, which is a type of cancer that starts in the cells lining the urinary tract, that is either locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body).
  • The cancer cannot be something that a doctor can successfully remove with resection (surgery) or treat with radiation (using high-energy beams to kill cancer cells) with the goal of a cure.
  • If you have HIV, it must be well-controlled using antiretroviral therapy (medicine used to manage the virus).
  • If you test positive for Hepatitis B, you must have been taking antiviral therapy (medicine to fight the virus) for at least 4 weeks and have an undetectable viral load (meaning the amount of virus in your blood is so low it cannot be measured).
  • If you have ever had Hepatitis C, the amount of virus in your blood must be undetectable.
  • Your organs, such as your liver and kidneys, must be functioning well.
  • Your cancer must be measurable, meaning it is large enough or clear enough to be tracked using specific medical imaging standards called RECIST 1.1.
  • You must have previously received anti-PD-[L]1 therapy (a type of immunotherapy), platinum-based chemotherapy (drugs that use platinum to kill cancer cells), and enfortumab vedotin.
  • You must have had a maximum of 3 prior lines of therapy (meaning you have tried up to three different types of previous cancer treatments).
  • Your cancer must have shown radiographic disease progression, which means imaging tests like scans show the cancer has grown or spread since your last treatment.
  • You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.
  • You must be able to receive at least one of the nonplatinum chemotherapy options provided in the study, such as paclitaxel, docetaxel, or vinflunine.
  • You must be able to provide a tumor tissue sample, either from stored old samples or through a new biopsy (a procedure to take a small piece of tissue), from a part of the tumor that has not been treated with radiation.

Who cannot join the trial?

16 criteria

  • You have a history of severe dry eye syndrome (a condition where eyes do not produce enough tears), Meibomian gland disease (a problem with the oil glands in the eyelids), blepharitis (inflammation of the eyelids), or corneal disease (damage to the clear front part of the eye) that stops the eye from healing properly.
  • You have already received certain types of chemotherapy (drugs used to kill cancer cells) for urothelial cancer, specifically paclitaxel, docetaxel, or vinflunine.
  • You have used an investigational agent (a drug being tested in a study) or an investigational device (a medical tool being tested) within 4 weeks before starting this study.
  • You have an immunodeficiency (a condition where your immune system is too weak to fight infection), are taking systemic steroids (medications that affect the whole body) for a long time, or are using any other immunosuppressive therapy (treatments that lower your body's ability to fight infection) within 7 days before the first dose.
  • You have another type of malignancy (cancer) that is currently growing or has needed active treatment in the last 3 years.
  • You have or have had central nervous system (CNS) metastases (cancer that has spread to the brain or spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
  • You have an active infection that requires systemic therapy (medicine that travels through the entire body, such as oral or IV medicine) other than the ones allowed by the study rules.
  • You have a history of having a stem cell transplant or a solid organ transplant (receiving a healthy organ from a donor).
  • You have not fully recovered from a major surgery or are currently experiencing surgical complications (problems following an operation).
  • You have cardiovascular disease (heart problems) or cerebrovascular disease (problems with blood vessels in the brain) that is not under control.
  • You have a history of pneumonitis (inflammation of the lung tissue) or interstitial lung disease (a group of disorders that cause scarring of the lungs) that required steroids, or you currently have these conditions.
  • You have HIV and a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (specific types of rare cancers or immune system disorders).
  • You have received cancer treatment within 4 weeks (or a specific time based on how fast the drug leaves your body) and have not recovered from adverse events (side effects or harmful reactions) to a mild level or back to your normal state.
  • You have previously used a TROP2-targeted antibody drug conjugate (ADC) (a type of targeted cancer medicine) or a topoisomerase 1 inhibitor-containing ADC.
  • You have finished external radiotherapy (radiation treatment from outside the body) within 6 weeks or stereotactic radiotherapy (highly precise radiation) within 4 weeks, or you have radiation side effects that require corticosteroids (steroid medicines).
  • You have received a live or live-attenuated vaccine (a vaccine that uses a weakened form of a germ) within 30 days before your first dose; however, killed vaccines (vaccines that use dead germs) are allowed.
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Investigated drugs

  • Sacituzumab tirumotecan

    is the experimental therapy being tested in this study. It is a type of targeted treatment designed to deliver medication directly to cancer cells.

  • Docetaxel

    is a chemotherapy drug used as a comparison treatment to see how well the experimental drug works compared to standard care.

  • Vinflunine

    is a chemotherapy drug that may be used as one of the comparison treatments chosen by the doctor.

  • Paclitaxel

    is a chemotherapy drug that may be used as one of the comparison treatments chosen by the doctor.

What is already known about the treatment

  • Docetaxel

    This medication is an established chemotherapy drug administered through an intravenous infusion to treat various types of cancer. It belongs to a group called taxanes and works by preventing cancer cells from dividing, effectively stopping their growth. It is commonly used for patients with advanced cancers that have not responded to other treatments.

  • Sacituzumab tirumotecan

    This is an experimental drug currently being studied in clinical trials and is administered via intravenous infusion. It is classified as an antibody-drug conjugate, which means it uses a specialized protein to target specific markers on cancer cells and deliver a powerful medicine directly into them. Once inside the cell, the medication disrupts the cell's internal structure to stop it from multiplying.

  • Vinflunine

    This is a known chemotherapy agent that is given to patients through an intravenous infusion to treat certain types of cancer. As a vinca alkaloid, it works at the cellular level by interfering with the machinery that allows cells to split and multiply. It is used as a specialized treatment for patients with advanced malignancies.

  • Paclitaxel

    This is a widely used chemotherapy medication delivered to the patient through an intravenous infusion. It is classified as a taxane and functions by stabilizing the internal framework of cancer cells, which prevents them from dividing and growing. It is frequently used to treat several different types of advanced solid tumors.

Investigated diseases

Urothelial carcinoma - This is a type of cancer that starts in the urothelium, which is the lining of the urinary tract. The disease can begin in the bladder, but it may also develop in the ureters or the renal pelvis. As the condition progresses, it can grow locally into nearby tissues. In advanced stages, the cancer cells may spread from the initial site to distant parts of the body through the blood or lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520014-22-00Protocol codeMK-2870-031Estimated enrolment539 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).