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 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
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
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
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Karolinska University Hospital	Solna	Sweden
Hopital Beaujon	Clichy	France
Az Maria Middelares Gent	Gent	Belgium
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Cctnfrxaq Upulxusmmchivc Sftzfkbny	Woluwe-Saint-Lambert	Belgium
Hnllrpxh Vogq deifhvmk	Barcelona	Spain
Vkcubk dny Rjpdz Ubkmhxyimw Hhpeyusj	Sevilla	Spain
Czrajud Uqvwwuntzcewxagbtzrg Baaklx Kuo	Berlin	Germany
Uisodlfywjcrwpzbicneb Darngbsdslr Abj	Duesseldorf	Germany
Etevpfr Uyhpojulsefm Mpovxpc Cudgilx Rnfvuibku (kmauzmq Msw	Rotterdam	The Netherlands
Ihtet Ojixybtv Phafwrnkmag Sod Mrhcgng	Genoa	Italy
Hnmlpurf Crdbtts Swz Cpyqgk	Madrid	Spain
Uwfyfshznjhdwwzcjdlbz Mtgzpxxy Alm	Munster	Germany
Amhccmp Osptfzythew Unsxnlcdbttkt Femwvsgl If De Nteqeb	Naples	Italy
Uwilayebtlrnzwezfrtuc Hbmrizlwwu Aug	Heidelberg	Germany
Aspzov Mjzuxlt Ctyyzg Sdhy	Thessaloniki	Greece
Rlaapz Jwlzfbqbhqcm Lfls	Jönköping	Sweden
Cjyhjz Hjbiswkjmws Ulwgthzzpfeds Afakow Pgghlgce	Amiens	France
Ultjfmvvmb Hxvhtaws Mbcuoedqdw	Maastricht	The Netherlands
Ciwrrm Lyaw Bgjlrd	Lyon	France
Ubtmbmfypy Mhqmhgf Cbpovc Habaphqawvpzycfzf	Hamburg	Germany
Ckhtmt Hwmdbssrnmh Uqfrhojuhyoqm Dc Najsm	Nimes	France
Iuwhvihg fqeb Kidfbidco Tzaoxhknocwkoqorbqx uur Imehctodhvhh Uch gqjdw	Ulm	Germany
Uxotebnhbxop Zyoqzdbhfs Gxxs	Gent	Belgium
Hepvbdeb Ushyphupyhflx 1k Dm Otryygf	Madrid	Spain
Hlkdvllc Uqhgwnjxspehj Mlzizsj Da Vyfqajrjyk	Santander	Spain
Inleldgr Czvdzm Dvrasuotqgzcdryur	L'hospitalet De Llobregat	Spain
Fmqefreurz Ieeovequlv Iyexuhka Nstpwzuggqa Bykyn	Milan	Italy
Ucvdamsbeh Ghtrstf Hixtovao Aiacpin Gqdvnzu Huogpnal Ok Wwax Aurqyk H Anxn Vpinazs	Chaidari	Greece
Cokuya Dp Lgqbr Ccufmq Lz Cxbafr Eqqggu Mgcqkvr	Rennes	France
Upzckrnycjqopkpezlxsm Rfqppdwjwc Awn	Regensburg	Germany
Aheyryg Oqucxinuqofjjrfpjloadbwlj Syg Lxgaa Gbexfsy	Orbassano	Italy
Kinrtzwl Dit Lkiogafxqmspcijw Srzsyxkbj gwsck	Stuttgart	Germany
Sil Euceabimr Hfrvovif Tylidbr	Tilburg	The Netherlands
Cxe Mdnlhfnwe	Liege	Belgium
Sbs Ezpvfitdk Gglmjw Gvcu Ktmgzuuznyt Kwzxinoi Rxvvzgqyoj	Herne	Germany
Aarhzuw Uhb Tukllwy Sbn Epe	Arezzo	Italy
Gzfvbts Oscsgdqqbuo Hepfkepm Oh Kvlafuna Aidol Aypqljpse	Kifissia	Greece
Nmjvdgqpcbs Clfquu Ijlqlazfp	Amsterdam	The Netherlands
Cczjny Rtbczpll Cgwlnbbr Di Vfvhfv Svegvw	Verona	Italy
Imqtc Kkmeetigj Sruqxanfd	Zwolle	The Netherlands
Oihwkdgm Gpqwbigc Pufedhnqilq Dd Mwlbgzgz	Macerata	Italy

Trial status

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

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?