En klinisk studie av Sacituzumab Tirumotecan (Sac-TMT, MK-2870) for behandling av urotelcellekreft (MK-2870-031) (TroFuse-031)
En fase 3, randomisert, åpen studie av Sacituzumab Tirumotecan (MK-2870) mot forskerens valg av ikke-platinabaserte kjemoterapier hos deltakere med tidligere behandlet lokalt avansert/metastatisk urotelialkarsinom
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
- Rekruttering
- Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01145744343
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABD
- Rekruttering
- Hospital Italiano de Buenos Aires ( Site 0004)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5491155933332
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming ( Site 0002)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +541132218900
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000KZE
- Rekruttering
- Instituto de Oncologia de Rosario ( Site 0005)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0341156602277
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New South Wales
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Macquarie, New South Wales, Australia, 2109
- Rekruttering
- Macquarie University ( Site 0031)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +61298505721
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Rekruttering
- Mater Hospital Brisbane ( Site 0032)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +61731637689
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Liège, Belgia, 4000
- Rekruttering
- CHC Montlegia Clinic ( Site 0061)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 043554213
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Bruxelles-Capitale, Region de
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Brussels, Bruxelles-Capitale, Region de, Belgia, 1200
- Rekruttering
- Cliniques Universitaires Saint-Luc ( Site 0062)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +32 2 764 42 95
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
- Rekruttering
- AZ Maria Middelares ( Site 0063)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3292469522
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Ghent, Oost-Vlaanderen, Belgia, 9000
- Rekruttering
- UZ Gent ( Site 0064)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +32 9 332 57 93
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São Paulo, Brasil, 01327-001
- Rekruttering
- Hospital Alemao Oswaldo Cruz ( Site 0101)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +551135490398
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Paraná
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Curitiba, Paraná, Brasil, 80510-130
- Rekruttering
- ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +554133361110
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90560-032
- Rekruttering
- Hospital Moinhos de Vento ( Site 0102)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +55 51 3314-3209
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São Paulo
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Rekruttering
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +551732015000
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Ontario
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Oshawa, Ontario, Canada, L1G 2B9
- Rekruttering
- Lakeridge Health ( Site 0122)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 905-576-8711
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre ( Site 0123)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 416-340-4800 x8626
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Quebec
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Québec, Quebec, Canada, G1J 1Z4
- Rekruttering
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 4185254444
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20016
- Rekruttering
- Sibley Memorial Hospital ( Site 0849)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 202-537-4000
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Emory University Hospital ( Site 0824)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 404-778-1900
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Johns Hopkins University ( Site 0843)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 240-893-4786
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute ( Site 0783)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 617-632-3466
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Michigan
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Traverse City, Michigan, Forente stater, 49684
- Rekruttering
- Munson Medical Center ( Site 0812)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 231-392-8400
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Rekruttering
- Morristown Memorial Hospital ( Site 0795)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 937-917-5000
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New York
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center ( Site 0832)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 347-798-9213
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North Carolina
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Raleigh, North Carolina, Forente stater, 27610
- Rekruttering
- WakeMed Raleigh Campus ( Site 0811)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 919-350-8585
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Ohio
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Cincinnati, Ohio, Forente stater, 45220
- Rekruttering
- TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 513-865-5249
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals of Cleveland Case Medical Center ( Site 0834)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-844-6031
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic - Ohio ( Site 0793)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 866-233-8100
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111
- Rekruttering
- Fox Chase Cancer Center ( Site 0830)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 888-369-2427
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- The West Clinic, P.C. ( Site 0791)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 901-683-0055
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Knoxville, Tennessee, Forente stater, 37916
- Rekruttering
- Thompson Cancer Survival Center ( Site 0803)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 865-331-1720
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 877-836-6662
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- University of Utah, Huntsman Cancer Institute ( Site 0810)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 801-587-7000
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Virginia
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Norfolk, Virginia, Forente stater, 23502
- Rekruttering
- Virginia Oncology Associates (VOA) ( Site 8002)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 757-466-8663
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Washington
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Seattle, Washington, Forente stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Research Center ( Site 0787)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 206-606-1943
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Finistere
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Brest, Finistere, Frankrike, 29200
- Rekruttering
- CHRU de Brest ( Site 0272)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33298223395
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35042
- Rekruttering
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0280)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33299253182
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Thessaloniki, Hellas, 570 01
- Rekruttering
- European Interbalkan Medical Center ( Site 0331)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302310390766
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Attica
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Athens, Attica, Hellas, 145 64
- Rekruttering
- General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302103501317
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Athens, Attica, Hellas, 155 62
- Rekruttering
- METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302106502831
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Chaïdári, Attica, Hellas, 124 61
- Rekruttering
- University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302105832549
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Marousi, Attica, Hellas, 151 25
- Rekruttering
- Athens Medical Center ( Site 0336)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +302106862169
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus ( Site 0362)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 04-7776234
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Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Medical Center ( Site 0366)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97226555999
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Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center ( Site 0364)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-3-9378074
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Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center ( Site 0361)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97235303030
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Tsrifin, Israel, 7033001
- Rekruttering
- Yitzhak Shamir Medical Center. ( Site 0367)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-8-9542196
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Arezzo, Italia, 52100
- Rekruttering
- Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390575255446
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Genova, Italia, 16132
- Rekruttering
- IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390105553307
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Milan, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 02 2390 1
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390630154953
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Milano
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Rozzano, Milano, Italia, 20089
- Rekruttering
- Istituto Clinico Humanitas ( Site 0398)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00390282244061
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Napoli
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Naples, Napoli, Italia, 80131
- Rekruttering
- Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 0399)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0817472223
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Piedmont
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Orbassano, Piedmont, Italia, 10043
- Rekruttering
- Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 00390119026534
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Veneto
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Verona, Veneto, Italia, 37134
- Rekruttering
- Centro Ricerche Cliniche di Verona ( Site 0393)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 045 8126509
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Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital ( Site 0434)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-92-641-1151
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Gifu, Japan, 501-1194
- Rekruttering
- Gifu University Hospital ( Site 0427)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-58-230-6000
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Kyoto, Japan, 606-8507
- Rekruttering
- Kyoto University Hospital ( Site 0433)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-75-751-3111
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 466-8560
- Rekruttering
- Nagoya University Hospital ( Site 0429)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-52-741-2111
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Aomori
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Hirosaki, Aomori, Japan, 036-8563
- Rekruttering
- Hirosaki University Hospital ( Site 0435)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-172-33-5111
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Ehime
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Tōon, Ehime, Japan, 791-0295
- Rekruttering
- Ehime University Hospital ( Site 0430)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-89-964-5111
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 0436)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Rekruttering
- Kobe University Hospital ( Site 0431)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-78-382-5111
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Ibaraki
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Tsukuba, Ibaraki, Japan, 305-8576
- Rekruttering
- University of Tsukuba Hospital ( Site 0432)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-29-853-3900
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Kagawa-ken
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Kita-gun, Kagawa-ken, Japan, 761-0793
- Rekruttering
- Kagawa University Hospital ( Site 0424)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-87-898-5111
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Kanagawa
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Kawasaki, Kanagawa, Japan, 216-8511
- Rekruttering
- St. Marianna University Hospital ( Site 0422)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-44-977-8111
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Sagamihara, Kanagawa, Japan, 252-0375
- Rekruttering
- Kitasato University Hospital ( Site 0425)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-42-778-8111
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Nara
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Kashihara, Nara, Japan, 634-8522
- Rekruttering
- Nara Medical University Hospital ( Site 0423)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-744-22-3051
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Osaka
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Sakai, Osaka, Japan, 591-8025
- Rekruttering
- Osaka Rosai Hospital ( Site 0428)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-72-252-3561
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Tokyo
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Bunkyo, Tokyo, Japan, 113-8519
- Rekruttering
- Institute of Science Tokyo Hospital ( Site 0421)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-33-813-6111
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Koto, Tokyo, Japan, 135-8550
- Rekruttering
- Cancer Institute Hospital of JFCR ( Site 0426)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3520-0111
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100034
- Rekruttering
- Peking University First Hospital ( Site 0184)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 010-83572211
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400010
- Rekruttering
- The First Affiliated Hospital of Chonqing Medical University ( Site 0197)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02389012012
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-Sen University Cancer Center ( Site 0183)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8602087343533
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-Sen University Cancer Center ( Site 0188)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8602087343533
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Guangzhou, Guangdong, Kina, 510280
- Rekruttering
- Zhujiang Hospital of Southern Medical University ( Site 0205)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 020-61643888
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Guangzhou, Guangdong, Kina, 510288
- Rekruttering
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 020-81332199
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Zhuhai, Guangdong, Kina, 519000
- Rekruttering
- The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0756-25286878
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Hubei
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Wuhan, Hubei, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 027-85726685
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Hunan
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Changsha, Hunan, Kina, 410011
- Rekruttering
- The Second Xiangya Hospital of Central South University ( Site 0916)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 073185295888
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Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital ( Site 0182)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0731-89761269
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Jiangsu
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Nanjing, Jiangsu, Kina, 210009
- Rekruttering
- Jiangsu Cancer Hospital ( Site 0917)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 025-83283597
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Rekruttering
- Jiangxi Cancer Hospital ( Site 0192)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0791-88305561
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center ( Site 0181)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 021-64175590
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Zhongshan Hospital Fudan University ( Site 0907)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02164041990
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital of Sichuan University ( Site 0185)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 028-85422707
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300211
- Rekruttering
- The Second Hospital of Tianjin Medical University ( Site 0910)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8613662096232
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Zhejiang
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Jiaxing, Zhejiang, Kina, 314033
- Rekruttering
- The First Hospital of Jiaxing ( Site 0901)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0573 8208 2937
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Ningbo, Zhejiang, Kina, 315201
- Rekruttering
- The First Affiliated Hospital of Ningbo University ( Site 0193)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0574-87075577
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Wenzhou, Zhejiang, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 025-83106666
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Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +8613738301029
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Utrecht, Nederland, 3543 AZ
- Rekruttering
- St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31883205148
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Gelderland
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Nijmegen, Gelderland, Nederland, 6525 GA
- Rekruttering
- Radboudumc ( Site 0487)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31243610353
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Limburg
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Maastricht, Limburg, Nederland, 6229 HX
- Rekruttering
- Maastricht UMC+ ( Site 0483)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31433877025
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North Holland
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Amsterdam, North Holland, Nederland, 1066 CX
- Rekruttering
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31205129111
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Tilburg, North Holland, Nederland, 5022 GC
- Rekruttering
- Elisabeth-TweeSteden Ziekenhuis ( Site 0489)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31132210420
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Overijssel
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Zwolle, Overijssel, Nederland, 8025 AB
- Rekruttering
- Isala, locatie Zwolle ( Site 0486)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31886247573
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South Holland
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Rotterdam, South Holland, Nederland, 3015 GD
- Rekruttering
- Erasmus Medisch Centrum ( Site 0481)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31107040252
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Barcelona, Spania, 08035
- Rekruttering
- Hospital Universitari Vall d Hebron ( Site 0607)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34934893000
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Madrid, Spania, 28040
- Rekruttering
- Hospital Clinico San Carlos ( Site 0608)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 913303000
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Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre ( Site 0602)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 913 908 307
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Seville, Spania, 41013
- Rekruttering
- Hospital Virgen del Rocio ( Site 0601)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 95 501 30 68
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Rekruttering
- H. de Badalona Germans Trias I Pujol ( Site 0603)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 93 497 89 25
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Cantabria
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Santander, Cantabria, Spania, 39008
- Rekruttering
- Hospital Universitario Marques de Valdecilla ( Site 0605)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 942 20 25 25
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Las Palmas
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Las Palmas de Gran Canaria, Las Palmas, Spania, 35016
- Rekruttering
- Hospital Universitario Insular de Gran Canaria ( Site 0604)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34 92 844 17 38
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spania, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal ( Site 0606)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34913368263
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Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannia, CB2 0QQ
- Rekruttering
- Cambridge University Hospitals NHS Foundation Trust ( Site 0756)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01223 216083
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London, City of
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London, London, City of, Storbritannia, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital ( Site 0751)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 07437894656
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Jönköping County
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Jönköping, Jönköping County, Sverige, 551 85
- Rekruttering
- Laenssjukhuset Ryhov ( Site 0632)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46102410000
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Stockholm County
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Stockholm, Stockholm County, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset Solna ( Site 0631)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +46812370000
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Berlin, Tyskland, 10117
- Rekruttering
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 30 450 615 137
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sacituzumab tirumotecan
Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity. |
IV infusion
Andre navn:
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). |
|
Aktiv komparator: Chemotherapy
Participants 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. |
IV infusion IV infusion IV infusion 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 40 months
|
OS is defined as time from randomization to death due to any cause. |
Up to approximately 40 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: Up to approximately 32 months
|
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. |
Up to approximately 32 months
|
|
Objective Response Rate (ORR)
Tidsramme: Up to approximately 32 months
|
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. |
Up to approximately 32 months
|
|
Duration of Response (DOR)
Tidsramme: Up to approximately 49 months
|
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. |
Up to approximately 49 months
|
|
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 49 months
|
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. |
Up to approximately 49 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 48 months
|
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. |
Up to approximately 48 months
|
|
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
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
|
Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
|
Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
|
Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
|
Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score
Tidsramme: Baseline, up to approximately 49 months
|
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. |
Baseline, up to approximately 49 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Urologiske neoplasmer
- Urinblæresykdommer
- Neoplasmer i urinblæren
- Organiske kjemikalier
- Terapeutikk
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Taxoider
- Cyclodecanes
- Diterpenes
- Docetaxel
- Paclitaxel
- Medikamentell terapi
- Vinflunine
Andre studie-ID-numre
- 2870-031
- U1111-1316-4390 (Registeridentifikator: UTN)
- 2024-520014-22-00 (Registeridentifikator: EU CT)
- MK-2870-031 (Annen identifikator: MSD)
- jRCT2051260020 (Registeridentifikator: Japan Registry of Clinical Trial (jRCT))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
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