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

3 1 1 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Centre Jean Perrin Clermont Ferrand France
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Nimes Nimes France
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universitair Ziekenhuis Gent Gent Belgium
Isala Klinieken Stichting Zwolle The Netherlands
Hospital Universitario 12 De Octubre Madrid Spain
Az Maria Middelares Gent Gent Belgium
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Ospedale Generale Provinciale Di Macerata Macerata Italy
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
St. Antonius Ziekenhuis Nieuwegein The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
CHC MontLegia Liege Belgium
Region Joenkoepings Laen Jönköping Sweden
Centre Hospitalier Universitaire Amiens Picardie Amiens France
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Azienda USL Toscana Sud Est Arezzo Italy
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Netherlands Cancer Institute Amsterdam The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Cpsiyhjnw Uqbnfpvusxhjga Sgtirbxmp Woluwe-Saint-Lambert Belgium
Clsrfh Ldjl Bjyqrq Lyon France
Uqqqdgxinc Mzluhrp Cihcbi Htbzybhdzxhpeeflb Hamburg Germany
Hzzfhvwc Uzkmnrtmzyzvx Momroil Dz Vfookcvmft Santander Spain
Exiemho Uhlnhacjntyh Moagmot Ciddaoq Rmgjdehzz (zrcsmmq Mtr Rotterdam The Netherlands
Sql Etwgqlbeu Hygvgfni Txoufqr Tilburg The Netherlands
Ufgmsgtnnbqhgpbszsbfv Mdrjlfwk Azw Munster Germany
Ahnbqt Meptzvm Cvjosh Seol Thessaloniki Greece
Izndvhwh Cfocnt Dtuweqnmovlqkwiat L'hospitalet De Llobregat Spain
Uwcpfnzyzucoofwvatfbo Djjkwmtfjkw Atm Duesseldorf Germany
Hqezvgva Vjqw drygdlqh Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.04.2026
France France
Recruiting
30.04.2026
Germany Germany
Not yet recruiting
30.04.2026
Greece Greece
Recruiting
30.04.2026
Italy Italy
Recruiting
30.04.2026
Spain Spain
Recruiting
30.04.2026
Sweden Sweden
Recruiting
30.04.2026
The Netherlands The Netherlands
Recruiting
30.04.2026

Trial locations

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.

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 ID:
2024-520014-22-00
Protocol code:
MK-2870-031
Trial Phase:
Therapeutic confirmatory (Phase III)

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