AzTrials
AzTrials

Bladder CancerPhase 3TroFuse-031NCT07419295

A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)

A Phase 3 study testing Sacituzumab tirumotecan, Vinflunine and Docetaxel in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 111 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Sacituzumab tirumotecan, Vinflunine and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
111 sitesin 17 countries
Study dates
23 Apr 2026to 23 Apr 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

111 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

111 sites in 17 countries

China20 sites, 20 recruiting

  • Peking University First Hospital ( Site 0184)

    Beijing, Beijing Municipality, 100034

    Study Coordinator, 010-83572211

    Recruiting

  • The Second Xiangya Hospital of Central South University ( Site 0916)

    Changsha, Hunan, 410011

    Study Coordinator, 073185295888

    Recruiting

  • Hunan Cancer Hospital ( Site 0182)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89761269

    Recruiting

  • West China Hospital of Sichuan University ( Site 0185)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85422707

    Recruiting

  • The First Affiliated Hospital of Chonqing Medical University ( Site 0197)

    Chongqing, Chongqing Municipality, 400010

    Study Coordinator, 02389012012

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 0183)

    Guangzhou, Guangdong, 510060

    Study Coordinator, +8602087343533

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 0188)

    Guangzhou, Guangdong, 510060

    Study Coordinator, +8602087343533

    Recruiting

  • Zhujiang Hospital of Southern Medical University ( Site 0205)

    Guangzhou, Guangdong, 510280

    Study Coordinator, 020-61643888

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189)

    Guangzhou, Guangdong, 510288

    Study Coordinator, 020-81332199

    Recruiting

  • The First Hospital of Jiaxing ( Site 0901)

    Jiaxing, Zhejiang, 314033

    Study Coordinator, 0573 8208 2937

    Recruiting

  • Jiangxi Cancer Hospital ( Site 0192)

    Nanchang, Jiangxi, 330029

    Study Coordinator, 0791-88305561

    Recruiting

  • Jiangsu Cancer Hospital ( Site 0917)

    Nanjing, Jiangsu, 210009

    Study Coordinator, 025-83283597

    Recruiting

  • The First Affiliated Hospital of Ningbo University ( Site 0193)

    Ningbo, Zhejiang, 315201

    Study Coordinator, 0574-87075577

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 0181)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-64175590

    Recruiting

  • Zhongshan Hospital Fudan University ( Site 0907)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 02164041990

    Recruiting

  • The Second Hospital of Tianjin Medical University ( Site 0910)

    Tianjin, Tianjin Municipality, 300211

    Study Coordinator, +8613662096232

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)

    Wenzhou, Zhejiang, 210008

    Study Coordinator, 025-83106666

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)

    Wenzhou, Zhejiang, 325000

    Study Coordinator, +8613738301029

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)

    Wuhan, Hubei, 430022

    Study Coordinator, 027-85726685

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)

    Zhuhai, Guangdong, 519000

    Study Coordinator, 0756-25286878

    Recruiting

Other trials in China

United States18 sites, 18 recruiting

  • Emory University Hospital ( Site 0824)

    Atlanta, Georgia, 30322

    Study Coordinator, 404-778-1900

    Recruiting

  • Johns Hopkins University ( Site 0843)

    Baltimore, Maryland, 21287

    Study Coordinator, 240-893-4786

    Recruiting

  • Dana Farber Cancer Institute ( Site 0783)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-632-3466

    Recruiting

  • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)

    Cincinnati, Ohio, 45220

    Study Coordinator, 513-865-5249

    Recruiting

  • University Hospitals of Cleveland Case Medical Center ( Site 0834)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-844-6031

    Recruiting

  • Cleveland Clinic - Ohio ( Site 0793)

    Cleveland, Ohio, 44195

    Study Coordinator, 866-233-8100

    Recruiting

  • The West Clinic, P.C. ( Site 0791)

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0055

    Recruiting

  • Thompson Cancer Survival Center ( Site 0803)

    Knoxville, Tennessee, 37916

    Study Coordinator, 865-331-1720

    Recruiting

  • Morristown Memorial Hospital ( Site 0795)

    Morristown, New Jersey, 07960

    Study Coordinator, 937-917-5000

    Recruiting

  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)

    Nashville, Tennessee, 37203

    Study Coordinator, 877-836-6662

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0832)

    New York, New York, 10065

    Study Coordinator, 347-798-9213

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8002)

    Norfolk, Virginia, 23502

    Study Coordinator, 757-466-8663

    Recruiting

  • Fox Chase Cancer Center ( Site 0830)

    Philadelphia, Pennsylvania, 19111

    Study Coordinator, 888-369-2427

    Recruiting

  • WakeMed Raleigh Campus ( Site 0811)

    Raleigh, North Carolina, 27610

    Study Coordinator, 919-350-8585

    Recruiting

  • University of Utah, Huntsman Cancer Institute ( Site 0810)

    Salt Lake City, Utah, 84112

    Study Coordinator, 801-587-7000

    Recruiting

  • Fred Hutchinson Cancer Research Center ( Site 0787)

    Seattle, Washington, 98109

    Study Coordinator, 206-606-1943

    Recruiting

  • Munson Medical Center ( Site 0812)

    Traverse City, Michigan, 49684

    Study Coordinator, 231-392-8400

    Recruiting

  • Sibley Memorial Hospital ( Site 0849)

    Washington D.C., District of Columbia, 20016

    Study Coordinator, 202-537-4000

    Recruiting

Other trials in United States

Japan16 sites, 16 recruiting

  • Institute of Science Tokyo Hospital ( Site 0421)

    Bunkyo, Tokyo, 113-8519

    Study Coordinator, +81-33-813-6111

    Recruiting

  • Kyushu University Hospital ( Site 0434)

    Fukuoka, 812-8582

    Study Coordinator, +81-92-641-1151

    Recruiting

  • Gifu University Hospital ( Site 0427)

    Gifu, 501-1194

    Study Coordinator, +81-58-230-6000

    Recruiting

  • Hirosaki University Hospital ( Site 0435)

    Hirosaki, Aomori, 036-8563

    Study Coordinator, +81-172-33-5111

    Recruiting

  • Nara Medical University Hospital ( Site 0423)

    Kashihara, Nara, 634-8522

    Study Coordinator, +81-744-22-3051

    Recruiting

  • St. Marianna University Hospital ( Site 0422)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Kagawa University Hospital ( Site 0424)

    Kita-gun, Kagawa-ken, 761-0793

    Study Coordinator, +81-87-898-5111

    Recruiting

  • Kobe University Hospital ( Site 0431)

    Kobe, Hyōgo, 650-0017

    Study Coordinator, +81-78-382-5111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 0426)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kyoto University Hospital ( Site 0433)

    Kyoto, 606-8507

    Study Coordinator, +81-75-751-3111

    Recruiting

  • Nagoya University Hospital ( Site 0429)

    Nagoya, Aichi-ken, 466-8560

    Study Coordinator, +81-52-741-2111

    Recruiting

  • Kitasato University Hospital ( Site 0425)

    Sagamihara, Kanagawa, 252-0375

    Study Coordinator, +81-42-778-8111

    Recruiting

  • Osaka Rosai Hospital ( Site 0428)

    Sakai, Osaka, 591-8025

    Study Coordinator, +81-72-252-3561

    Recruiting

  • Hokkaido University Hospital ( Site 0436)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Ehime University Hospital ( Site 0430)

    Tōon, Ehime, 791-0295

    Study Coordinator, +81-89-964-5111

    Recruiting

  • University of Tsukuba Hospital ( Site 0432)

    Tsukuba, Ibaraki, 305-8576

    Study Coordinator, +81-29-853-3900

    Recruiting

Other trials in Japan

Italy8 sites, 8 recruiting

  • Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)

    Arezzo, 52100

    Study Coordinator, +390575255446

    Recruiting

  • IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)

    Genova, 16132

    Study Coordinator, +390105553307

    Recruiting

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)

    Milan, 20133

    Study Coordinator, +39 02 2390 1

    Recruiting

  • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 0399)

    Naples, Napoli, 80131

    Study Coordinator, 0817472223

    Recruiting

  • Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391)

    Orbassano, Piedmont, 10043

    Study Coordinator, 00390119026534

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)

    Roma, 00168

    Study Coordinator, +390630154953

    Recruiting

  • Istituto Clinico Humanitas ( Site 0398)

    Rozzano, Milano, 20089

    Study Coordinator, 00390282244061

    Recruiting

  • Centro Ricerche Cliniche di Verona ( Site 0393)

    Verona, Veneto, 37134

    Study Coordinator, +39 045 8126509

    Recruiting

Other trials in Italy

Spain8 sites, 8 recruiting

  • H. de Badalona Germans Trias I Pujol ( Site 0603)

    Badalona, Barcelona, 08916

    Study Coordinator, 93 497 89 25

    Recruiting

  • Hospital Universitari Vall d Hebron ( Site 0607)

    Barcelona, 08035

    Study Coordinator, +34934893000

    Recruiting

  • Hospital Universitario Insular de Gran Canaria ( Site 0604)

    Las Palmas de Gran Canaria, Las Palmas, 35016

    Study Coordinator, +34 92 844 17 38

    Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 0606)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, +34913368263

    Recruiting

  • Hospital Clinico San Carlos ( Site 0608)

    Madrid, 28040

    Study Coordinator, 913303000

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 0602)

    Madrid, 28041

    Study Coordinator, +34 913 908 307

    Recruiting

  • Hospital Universitario Marques de Valdecilla ( Site 0605)

    Santander, Cantabria, 39008

    Study Coordinator, +34 942 20 25 25

    Recruiting

  • Hospital Virgen del Rocio ( Site 0601)

    Seville, 41013

    Study Coordinator, +34 95 501 30 68

    Recruiting

Other trials in Spain

Netherlands7 sites, 7 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205129111

    Recruiting

  • Maastricht UMC+ ( Site 0483)

    Maastricht, Limburg, 6229 HX

    Study Coordinator, +31433877025

    Recruiting

  • Radboudumc ( Site 0487)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31243610353

    Recruiting

  • Erasmus Medisch Centrum ( Site 0481)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +31107040252

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis ( Site 0489)

    Tilburg, North Holland, 5022 GC

    Study Coordinator, +31132210420

    Recruiting

  • St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)

    Utrecht, 3543 AZ

    Study Coordinator, +31883205148

    Recruiting

  • Isala, locatie Zwolle ( Site 0486)

    Zwolle, Overijssel, 8025 AB

    Study Coordinator, +31886247573

    Recruiting

Other trials in Netherlands

Greece5 sites, 5 recruiting

  • General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)

    Athens, Attica, 145 64

    Study Coordinator, +302103501317

    Recruiting

  • METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)

    Athens, Attica, 155 62

    Study Coordinator, +302106502831

    Recruiting

  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)

    Chaïdári, Attica, 124 61

    Study Coordinator, +302105832549

    Recruiting

  • Athens Medical Center ( Site 0336)

    Marousi, Attica, 151 25

    Study Coordinator, +302106862169

    Recruiting

  • European Interbalkan Medical Center ( Site 0331)

    Thessaloniki, 570 01

    Study Coordinator, +302310390766

    Recruiting

Other trials in Greece

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 0362)

    Haifa, 3109601

    Study Coordinator, 04-7776234

    Recruiting

  • Shaare Zedek Medical Center ( Site 0366)

    Jerusalem, 9103102

    Study Coordinator, +97226555999

    Recruiting

  • Rabin Medical Center ( Site 0364)

    Petah Tikva, 4941492

    Study Coordinator, 972-3-9378074

    Recruiting

  • Sheba Medical Center ( Site 0361)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Yitzhak Shamir Medical Center. ( Site 0367)

    Tsrifin, 7033001

    Study Coordinator, 972-8-9542196

    Recruiting

Other trials in Israel

Argentina4 sites, 4 recruiting

  • Hospital Italiano de Buenos Aires ( Site 0004)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABD

    Study Coordinator, +5491155933332

    Recruiting

  • Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1419AHN

    Study Coordinator, 01145744343

    Recruiting

  • Instituto Alexander Fleming ( Site 0002)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Instituto de Oncologia de Rosario ( Site 0005)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, 0341156602277

    Recruiting

Other trials in Argentina

Belgium4 sites, 4 recruiting

  • Cliniques Universitaires Saint-Luc ( Site 0062)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +32 2 764 42 95

    Recruiting

  • AZ Maria Middelares ( Site 0063)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3292469522

    Recruiting

  • UZ Gent ( Site 0064)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 332 57 93

    Recruiting

  • CHC Montlegia Clinic ( Site 0061)

    Liège, 4000

    Study Coordinator, 043554213

    Recruiting

Other trials in Belgium

Brazil4 sites, 4 recruiting

  • ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)

    Curitiba, Paraná, 80510-130

    Study Coordinator, +554133361110

    Recruiting

  • Hospital Moinhos de Vento ( Site 0102)

    Porto Alegre, Rio Grande do Sul, 90560-032

    Study Coordinator, +55 51 3314-3209

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)

    São José do Rio Preto, São Paulo, 15090-000

    Study Coordinator, +551732015000

    Recruiting

  • Hospital Alemao Oswaldo Cruz ( Site 0101)

    São Paulo, 01327-001

    Study Coordinator, +551135490398

    Recruiting

Other trials in Brazil

Canada3 sites, 3 recruiting

  • Lakeridge Health ( Site 0122)

    Oshawa, Ontario, L1G 2B9

    Study Coordinator, 905-576-8711

    Recruiting

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)

    Québec, Quebec, G1J 1Z4

    Study Coordinator, 4185254444

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0123)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-340-4800 x8626

    Recruiting

Other trials in Canada

Australia2 sites, 2 recruiting

  • Macquarie University ( Site 0031)

    Macquarie, New South Wales, 2109

    Study Coordinator, +61298505721

    Recruiting

  • Mater Hospital Brisbane ( Site 0032)

    South Brisbane, Queensland, 4101

    Study Coordinator, +61731637689

    Recruiting

Other trials in Australia

France2 sites, 2 recruiting

  • CHRU de Brest ( Site 0272)

    Brest, Finistere, 29200

    Study Coordinator, +33298223395

    Recruiting

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0280)

    Rennes, Ille-et-Vilaine, 35042

    Study Coordinator, +33299253182

    Recruiting

Other trials in France

Sweden2 sites, 2 recruiting

  • Laenssjukhuset Ryhov ( Site 0632)

    Jönköping, Jönköping County, 551 85

    Study Coordinator, +46102410000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 0631)

    Stockholm, Stockholm County, 171 76

    Study Coordinator, +46812370000

    Recruiting

Other trials in Sweden

United Kingdom2 sites, 2 recruiting

  • Cambridge University Hospitals NHS Foundation Trust ( Site 0756)

    Cambridge, Cambridgeshire, CB2 0QQ

    Study Coordinator, 01223 216083

    Recruiting

  • St Bartholomew's Hospital ( Site 0751)

    London, London, City of, EC1A 7BE

    Study Coordinator, 07437894656

    Recruiting

Other trials in United Kingdom

Germany1 site, 1 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)

    Berlin, 10117

    Study Coordinator, +49 30 450 615 137

    Recruiting

Other trials in Germany

About this study

Official title: 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

Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.

Researchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.

Conditions
Bladder Cancer
Being tested
Sacituzumab tirumotecan, Vinflunine, Docetaxel, Paclitaxel, Rescue medications for sacituzumab tirumotecan
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanBiological

    Also called MK-2870, SKB264, sac-TMT

    IV infusion

  • VinflunineDrug

    IV infusion

  • DocetaxelDrug

    IV infusion

  • PaclitaxelDrug

    IV infusion

  • Rescue medications for sacituzumab tirumotecanDrug

    Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

  • Rescue medications for chemotherapyDrug

    Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.

Study groups in NCT07419295
Study groupRoleWhat they receive
Sacituzumab tirumotecanExperimentalParticipants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medications for sacituzumab tirumotecan
ChemotherapyActive comparatorParticipants receive paclitaxel 175 mg/m^2, docetaxel 75 mg/m^2, or vinflunine 320 mg/m^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.
Receives: Drug: Vinflunine; Drug: Docetaxel; Drug: Paclitaxel; Drug: Rescue medications for chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as time from randomization to death due to any cause.

    Measured: Up to approximately 40 months

Secondary outcomes (11)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.

    Measured: Up to approximately 32 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by the investigator will be presented.

    Measured: Up to approximately 32 months

  3. Duration of Response (DOR)

    For participants who demonstrate a confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.

    Measured: Up to approximately 49 months

  4. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.

    Measured: Up to approximately 49 months

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 48 months

  6. Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score will be presented.

    Measured: Baseline, up to approximately 49 months

  7. Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.

    Measured: Baseline, up to approximately 49 months

  8. Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning (Items 6 and 7) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 6 and 7 is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 role functioning (items 6 and 7) combined score will be presented.

    Measured: Baseline, up to approximately 49 months

  9. Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 3 questions about their fatigue (Items 10, 12, and 18) are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score of items 10, 12, and 18 is computed by averaging the raw scores of the 3 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 fatigue (items 10, 12, and 18) combined score will be presented.

    Measured: Baseline, up to approximately 49 months

  10. Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their nausea and vomiting symptoms (Items 14 and 15) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 14 and 15 is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 nausea/vomiting (Items 14 and 15) combined score will be presented.

    Measured: Baseline, up to approximately 49 months

  11. Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score

    EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Have you had diarrhea?" (Item 17) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 diarrhea (Item 17) score will be presented.

    Measured: Baseline, up to approximately 49 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start23 Apr 2026
  3. Primary completion27 Jul 2029 (estimated)
  4. Study completion23 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07419295
Sponsor's protocol ID
2870-031
Other IDs
U1111-1316-4390, 2024-520014-22-00, MK-2870-031, jRCT2051260020
Acronym
TroFuse-031
Status last verified
Oct 2026
First submitted
10 Feb 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Vinflunine and Docetaxel in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 111 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in China, United States, Japan, Italy, Spain and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07419295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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