En klinisk prövning av Sacituzumab Tirumotecan (Sac-TMT, MK-2870) för behandling av urotelcancer (MK-2870-031) (TroFuse-031)
En fas 3, randomiserad, öppen studie av Sacituzumab Tirumotecan (MK-2870) jämfört med forskarens val av icke-platinabaserad kemioterapi hos deltagare med tidigare behandlad lokalavancerad/metastaserad urothelialcancer
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studieorter
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
- Rekrytering
- Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 01145744343
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABD
- Rekrytering
- Hospital Italiano de Buenos Aires ( Site 0004)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +5491155933332
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Rekrytering
- Instituto Alexander Fleming ( Site 0002)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +541132218900
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, S2000KZE
- Rekrytering
- Instituto de Oncologia de Rosario ( Site 0005)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0341156602277
-
-
-
-
New South Wales
-
Macquarie, New South Wales, Australien, 2109
- Rekrytering
- Macquarie University ( Site 0031)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +61298505721
-
-
Queensland
-
South Brisbane, Queensland, Australien, 4101
- Rekrytering
- Mater Hospital Brisbane ( Site 0032)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +61731637689
-
-
-
-
-
Liège, Belgien, 4000
- Rekrytering
- CHC Montlegia Clinic ( Site 0061)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 043554213
-
-
Bruxelles-Capitale, Region de
-
Brussels, Bruxelles-Capitale, Region de, Belgien, 1200
- Rekrytering
- Cliniques Universitaires Saint-Luc ( Site 0062)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +32 2 764 42 95
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgien, 9000
- Rekrytering
- AZ Maria Middelares ( Site 0063)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +3292469522
-
Ghent, Oost-Vlaanderen, Belgien, 9000
- Rekrytering
- UZ Gent ( Site 0064)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +32 9 332 57 93
-
-
-
-
-
São Paulo, Brasilien, 01327-001
- Rekrytering
- Hospital Alemao Oswaldo Cruz ( Site 0101)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +551135490398
-
-
Paraná
-
Curitiba, Paraná, Brasilien, 80510-130
- Rekrytering
- ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +554133361110
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90560-032
- Rekrytering
- Hospital Moinhos de Vento ( Site 0102)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +55 51 3314-3209
-
-
São Paulo
-
São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Rekrytering
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +551732015000
-
-
-
-
Finistere
-
Brest, Finistere, Frankrike, 29200
- Rekrytering
- CHRU de Brest ( Site 0272)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +33298223395
-
-
Ille-et-Vilaine
-
Rennes, Ille-et-Vilaine, Frankrike, 35042
- Rekrytering
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0280)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +33299253182
-
-
-
-
District of Columbia
-
Washington D.C., District of Columbia, Förenta staterna, 20016
- Rekrytering
- Sibley Memorial Hospital ( Site 0849)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 202-537-4000
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University Hospital ( Site 0824)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 404-778-1900
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21287
- Rekrytering
- Johns Hopkins University ( Site 0843)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 240-893-4786
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
- Dana Farber Cancer Institute ( Site 0783)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 617-632-3466
-
-
Michigan
-
Traverse City, Michigan, Förenta staterna, 49684
- Rekrytering
- Munson Medical Center ( Site 0812)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 231-392-8400
-
-
New Jersey
-
Morristown, New Jersey, Förenta staterna, 07960
- Rekrytering
- Morristown Memorial Hospital ( Site 0795)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 937-917-5000
-
-
New York
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center ( Site 0832)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 347-798-9213
-
-
North Carolina
-
Raleigh, North Carolina, Förenta staterna, 27610
- Rekrytering
- WakeMed Raleigh Campus ( Site 0811)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 919-350-8585
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45220
- Rekrytering
- TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 513-865-5249
-
Cleveland, Ohio, Förenta staterna, 44106
- Rekrytering
- University Hospitals of Cleveland Case Medical Center ( Site 0834)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 216-844-6031
-
Cleveland, Ohio, Förenta staterna, 44195
- Rekrytering
- Cleveland Clinic - Ohio ( Site 0793)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 866-233-8100
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Rekrytering
- Fox Chase Cancer Center ( Site 0830)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 888-369-2427
-
-
Tennessee
-
Germantown, Tennessee, Förenta staterna, 38138
- Rekrytering
- The West Clinic, P.C. ( Site 0791)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 901-683-0055
-
Knoxville, Tennessee, Förenta staterna, 37916
- Rekrytering
- Thompson Cancer Survival Center ( Site 0803)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 865-331-1720
-
Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 877-836-6662
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- University of Utah, Huntsman Cancer Institute ( Site 0810)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 801-587-7000
-
-
Virginia
-
Norfolk, Virginia, Förenta staterna, 23502
- Rekrytering
- Virginia Oncology Associates (VOA) ( Site 8002)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 757-466-8663
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98109
- Rekrytering
- Fred Hutchinson Cancer Research Center ( Site 0787)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 206-606-1943
-
-
-
-
-
Thessaloniki, Grekland, 570 01
- Rekrytering
- European Interbalkan Medical Center ( Site 0331)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +302310390766
-
-
Attica
-
Athens, Attica, Grekland, 145 64
- Rekrytering
- General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +302103501317
-
Athens, Attica, Grekland, 155 62
- Rekrytering
- METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +302106502831
-
Chaïdári, Attica, Grekland, 124 61
- Rekrytering
- University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +302105832549
-
Marousi, Attica, Grekland, 151 25
- Rekrytering
- Athens Medical Center ( Site 0336)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +302106862169
-
-
-
-
-
Haifa, Israel, 3109601
- Rekrytering
- Rambam Health Care Campus ( Site 0362)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 04-7776234
-
Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek Medical Center ( Site 0366)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +97226555999
-
Petah Tikva, Israel, 4941492
- Rekrytering
- Rabin Medical Center ( Site 0364)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 972-3-9378074
-
Ramat Gan, Israel, 5265601
- Rekrytering
- Sheba Medical Center ( Site 0361)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +97235303030
-
Tsrifin, Israel, 7033001
- Rekrytering
- Yitzhak Shamir Medical Center. ( Site 0367)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 972-8-9542196
-
-
-
-
-
Arezzo, Italien, 52100
- Rekrytering
- Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +390575255446
-
Genova, Italien, 16132
- Rekrytering
- IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +390105553307
-
Milan, Italien, 20133
- Rekrytering
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +39 02 2390 1
-
Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +390630154953
-
-
Milano
-
Rozzano, Milano, Italien, 20089
- Rekrytering
- Istituto Clinico Humanitas ( Site 0398)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 00390282244061
-
-
Napoli
-
Naples, Napoli, Italien, 80131
- Rekrytering
- Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 0399)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0817472223
-
-
Piedmont
-
Orbassano, Piedmont, Italien, 10043
- Rekrytering
- Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 00390119026534
-
-
Veneto
-
Verona, Veneto, Italien, 37134
- Rekrytering
- Centro Ricerche Cliniche di Verona ( Site 0393)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +39 045 8126509
-
-
-
-
-
Fukuoka, Japan, 812-8582
- Rekrytering
- Kyushu University Hospital ( Site 0434)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-92-641-1151
-
Gifu, Japan, 501-1194
- Rekrytering
- Gifu University Hospital ( Site 0427)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-58-230-6000
-
Kyoto, Japan, 606-8507
- Rekrytering
- Kyoto University Hospital ( Site 0433)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-75-751-3111
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 466-8560
- Rekrytering
- Nagoya University Hospital ( Site 0429)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-52-741-2111
-
-
Aomori
-
Hirosaki, Aomori, Japan, 036-8563
- Rekrytering
- Hirosaki University Hospital ( Site 0435)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-172-33-5111
-
-
Ehime
-
Tōon, Ehime, Japan, 791-0295
- Rekrytering
- Ehime University Hospital ( Site 0430)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-89-964-5111
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekrytering
- Hokkaido University Hospital ( Site 0436)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0017
- Rekrytering
- Kobe University Hospital ( Site 0431)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-78-382-5111
-
-
Ibaraki
-
Tsukuba, Ibaraki, Japan, 305-8576
- Rekrytering
- University of Tsukuba Hospital ( Site 0432)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-29-853-3900
-
-
Kagawa-ken
-
Kita-gun, Kagawa-ken, Japan, 761-0793
- Rekrytering
- Kagawa University Hospital ( Site 0424)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-87-898-5111
-
-
Kanagawa
-
Kawasaki, Kanagawa, Japan, 216-8511
- Rekrytering
- St. Marianna University Hospital ( Site 0422)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-44-977-8111
-
Sagamihara, Kanagawa, Japan, 252-0375
- Rekrytering
- Kitasato University Hospital ( Site 0425)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-42-778-8111
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Rekrytering
- Nara Medical University Hospital ( Site 0423)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-744-22-3051
-
-
Osaka
-
Sakai, Osaka, Japan, 591-8025
- Rekrytering
- Osaka Rosai Hospital ( Site 0428)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-72-252-3561
-
-
Tokyo
-
Bunkyo, Tokyo, Japan, 113-8519
- Rekrytering
- Institute of Science Tokyo Hospital ( Site 0421)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-33-813-6111
-
Koto, Tokyo, Japan, 135-8550
- Rekrytering
- Cancer Institute Hospital of JFCR ( Site 0426)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +81-3-3520-0111
-
-
-
-
Ontario
-
Oshawa, Ontario, Kanada, L1G 2B9
- Rekrytering
- Lakeridge Health ( Site 0122)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 905-576-8711
-
Toronto, Ontario, Kanada, M5G 2M9
- Rekrytering
- Princess Margaret Cancer Centre ( Site 0123)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 416-340-4800 x8626
-
-
Quebec
-
Québec, Quebec, Kanada, G1J 1Z4
- Rekrytering
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 4185254444
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100034
- Rekrytering
- Peking University First Hospital ( Site 0184)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 010-83572211
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 400010
- Rekrytering
- The First Affiliated Hospital of Chonqing Medical University ( Site 0197)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 02389012012
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510060
- Rekrytering
- Sun Yat-Sen University Cancer Center ( Site 0183)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +8602087343533
-
Guangzhou, Guangdong, Kina, 510060
- Rekrytering
- Sun Yat-Sen University Cancer Center ( Site 0188)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +8602087343533
-
Guangzhou, Guangdong, Kina, 510280
- Rekrytering
- Zhujiang Hospital of Southern Medical University ( Site 0205)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 020-61643888
-
Guangzhou, Guangdong, Kina, 510288
- Rekrytering
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 020-81332199
-
Zhuhai, Guangdong, Kina, 519000
- Rekrytering
- The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0756-25286878
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Rekrytering
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 027-85726685
-
-
Hunan
-
Changsha, Hunan, Kina, 410011
- Rekrytering
- The Second Xiangya Hospital of Central South University ( Site 0916)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 073185295888
-
Changsha, Hunan, Kina, 410013
- Rekrytering
- Hunan Cancer Hospital ( Site 0182)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0731-89761269
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210009
- Rekrytering
- Jiangsu Cancer Hospital ( Site 0917)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 025-83283597
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330029
- Rekrytering
- Jiangxi Cancer Hospital ( Site 0192)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0791-88305561
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Rekrytering
- Fudan University Shanghai Cancer Center ( Site 0181)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 021-64175590
-
Shanghai, Shanghai Municipality, Kina, 200032
- Rekrytering
- Zhongshan Hospital Fudan University ( Site 0907)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 02164041990
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Rekrytering
- West China Hospital of Sichuan University ( Site 0185)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 028-85422707
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300211
- Rekrytering
- The Second Hospital of Tianjin Medical University ( Site 0910)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +8613662096232
-
-
Zhejiang
-
Jiaxing, Zhejiang, Kina, 314033
- Rekrytering
- The First Hospital of Jiaxing ( Site 0901)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0573 8208 2937
-
Ningbo, Zhejiang, Kina, 315201
- Rekrytering
- The First Affiliated Hospital of Ningbo University ( Site 0193)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 0574-87075577
-
Wenzhou, Zhejiang, Kina, 210008
- Rekrytering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 025-83106666
-
Wenzhou, Zhejiang, Kina, 325000
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +8613738301029
-
-
-
-
-
Utrecht, Nederländerna, 3543 AZ
- Rekrytering
- St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31883205148
-
-
Gelderland
-
Nijmegen, Gelderland, Nederländerna, 6525 GA
- Rekrytering
- Radboudumc ( Site 0487)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31243610353
-
-
Limburg
-
Maastricht, Limburg, Nederländerna, 6229 HX
- Rekrytering
- Maastricht UMC+ ( Site 0483)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31433877025
-
-
North Holland
-
Amsterdam, North Holland, Nederländerna, 1066 CX
- Rekrytering
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31205129111
-
Tilburg, North Holland, Nederländerna, 5022 GC
- Rekrytering
- Elisabeth-TweeSteden Ziekenhuis ( Site 0489)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31132210420
-
-
Overijssel
-
Zwolle, Overijssel, Nederländerna, 8025 AB
- Rekrytering
- Isala, locatie Zwolle ( Site 0486)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31886247573
-
-
South Holland
-
Rotterdam, South Holland, Nederländerna, 3015 GD
- Rekrytering
- Erasmus Medisch Centrum ( Site 0481)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +31107040252
-
-
-
-
-
Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitari Vall d Hebron ( Site 0607)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34934893000
-
Madrid, Spanien, 28040
- Rekrytering
- Hospital Clinico San Carlos ( Site 0608)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 913303000
-
Madrid, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre ( Site 0602)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34 913 908 307
-
Seville, Spanien, 41013
- Rekrytering
- Hospital Virgen del Rocio ( Site 0601)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34 95 501 30 68
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Rekrytering
- H. de Badalona Germans Trias I Pujol ( Site 0603)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 93 497 89 25
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Rekrytering
- Hospital Universitario Marques de Valdecilla ( Site 0605)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34 942 20 25 25
-
-
Las Palmas
-
Las Palmas de Gran Canaria, Las Palmas, Spanien, 35016
- Rekrytering
- Hospital Universitario Insular de Gran Canaria ( Site 0604)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34 92 844 17 38
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spanien, 28034
- Rekrytering
- Hospital Universitario Ramon y Cajal ( Site 0606)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +34913368263
-
-
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Storbritannien, CB2 0QQ
- Rekrytering
- Cambridge University Hospitals NHS Foundation Trust ( Site 0756)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 01223 216083
-
-
London, City of
-
London, London, City of, Storbritannien, EC1A 7BE
- Rekrytering
- St Bartholomew's Hospital ( Site 0751)
-
Kontakt:
- Study Coordinator
- Telefonnummer: 07437894656
-
-
-
-
Jönköping County
-
Jönköping, Jönköping County, Sverige, 551 85
- Rekrytering
- Laenssjukhuset Ryhov ( Site 0632)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +46102410000
-
-
Stockholm County
-
Stockholm, Stockholm County, Sverige, 171 76
- Rekrytering
- Karolinska Universitetssjukhuset Solna ( Site 0631)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +46812370000
-
-
-
-
-
Berlin, Tyskland, 10117
- Rekrytering
- Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +49 30 450 615 137
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: Up to approximately 40 months
|
OS is defined as time from randomization to death due to any cause. |
Up to approximately 40 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urologiska neoplasmer
- Sjukdomar i urinblåsan
- Neoplasmer i urinblåsan
- Organiska kemikalier
- Terapeutik
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Taxoids
- Cyklodekaner
- Gentare
- Docetaxel
- Paklitaxel
- Narkotikabehandling
- vinflunin
Andra studie-ID-nummer
- 2870-031
- U1111-1316-4390 (Registeridentifierare: UTN)
- 2024-520014-22-00 (Registeridentifierare: EU CT)
- MK-2870-031 (Annan identifierare: MSD)
- jRCT2051260020 (Registeridentifierare: Japan Registry of Clinical Trial (jRCT))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .