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一项用于治疗尿路上皮癌的Sacituzumab Tirumotecan（Sac-TMT，MK-2870）临床试验（MK-2870-031） (TroFuse-031)

2026年11月6日 更新者：Merck Sharp & Dohme LLC

一项评估Sacituzumab Tirumotecan（MK-2870）对比研究者选择的非铂类化疗治疗经治局部晚期/转移性尿路上皮癌参与者的3期、随机、开放标签研究

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

590

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100034
        • 招聘中
        • Peking University First Hospital ( Site 0184)
        • 接触：
          • Study Coordinator
          • 电话号码：010-83572211
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400010
        • 招聘中
        • The First Affiliated Hospital of Chonqing Medical University ( Site 0197)
        • 接触：
          • Study Coordinator
          • 电话号码：02389012012
    • Guangdong
      • Guangzhou、Guangdong、中国、510060
        • 招聘中
        • Sun Yat-Sen University Cancer Center ( Site 0183)
        • 接触：
          • Study Coordinator
          • 电话号码：+8602087343533
      • Guangzhou、Guangdong、中国、510060
        • 招聘中
        • Sun Yat-Sen University Cancer Center ( Site 0188)
        • 接触：
          • Study Coordinator
          • 电话号码：+8602087343533
      • Guangzhou、Guangdong、中国、510280
        • 招聘中
        • Zhujiang Hospital of Southern Medical University ( Site 0205)
        • 接触：
          • Study Coordinator
          • 电话号码：020-61643888
      • Guangzhou、Guangdong、中国、510288
        • 招聘中
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189)
        • 接触：
          • Study Coordinator
          • 电话号码：020-81332199
      • Zhuhai、Guangdong、中国、519000
        • 招聘中
        • The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)
        • 接触：
          • Study Coordinator
          • 电话号码：0756-25286878
    • Hubei
      • Wuhan、Hubei、中国、430022
        • 招聘中
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)
        • 接触：
          • Study Coordinator
          • 电话号码：027-85726685
    • Hunan
      • Changsha、Hunan、中国、410011
        • 招聘中
        • The Second Xiangya Hospital of Central South University ( Site 0916)
        • 接触：
          • Study Coordinator
          • 电话号码：073185295888
      • Changsha、Hunan、中国、410013
        • 招聘中
        • Hunan Cancer Hospital ( Site 0182)
        • 接触：
          • Study Coordinator
          • 电话号码：0731-89761269
    • Jiangsu
      • Nanjing、Jiangsu、中国、210009
        • 招聘中
        • Jiangsu Cancer Hospital ( Site 0917)
        • 接触：
          • Study Coordinator
          • 电话号码：025-83283597
    • Jiangxi
      • Nanchang、Jiangxi、中国、330029
        • 招聘中
        • Jiangxi Cancer Hospital ( Site 0192)
        • 接触：
          • Study Coordinator
          • 电话号码：0791-88305561
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • 招聘中
        • Fudan University Shanghai Cancer Center ( Site 0181)
        • 接触：
          • Study Coordinator
          • 电话号码：021-64175590
      • Shanghai、Shanghai Municipality、中国、200032
        • 招聘中
        • Zhongshan Hospital Fudan University ( Site 0907)
        • 接触：
          • Study Coordinator
          • 电话号码：02164041990
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 招聘中
        • West China Hospital of Sichuan University ( Site 0185)
        • 接触：
          • Study Coordinator
          • 电话号码：028-85422707
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300211
        • 招聘中
        • The Second Hospital of Tianjin Medical University ( Site 0910)
        • 接触：
          • Study Coordinator
          • 电话号码：+8613662096232
    • Zhejiang
      • Jiaxing、Zhejiang、中国、314033
        • 招聘中
        • The First Hospital of Jiaxing ( Site 0901)
        • 接触：
          • Study Coordinator
          • 电话号码：0573 8208 2937
      • Ningbo、Zhejiang、中国、315201
        • 招聘中
        • The First Affiliated Hospital of Ningbo University ( Site 0193)
        • 接触：
          • Study Coordinator
          • 电话号码：0574-87075577
      • Wenzhou、Zhejiang、中国、210008
        • 招聘中
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)
        • 接触：
          • Study Coordinator
          • 电话号码：025-83106666
      • Wenzhou、Zhejiang、中国、325000
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)
        • 接触：
          • Study Coordinator
          • 电话号码：+8613738301029
  • 以色列
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Health Care Campus ( Site 0362)
        • 接触：
          • Study Coordinator
          • 电话号码：04-7776234
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Medical Center ( Site 0366)
        • 接触：
          • Study Coordinator
          • 电话号码：+97226555999
      • Petah Tikva、以色列、4941492
        • 招聘中
        • Rabin Medical Center ( Site 0364)
        • 接触：
          • Study Coordinator
          • 电话号码：972-3-9378074
      • Ramat Gan、以色列、5265601
        • 招聘中
        • Sheba Medical Center ( Site 0361)
        • 接触：
          • Study Coordinator
          • 电话号码：+97235303030
      • Tsrifin、以色列、7033001
        • 招聘中
        • Yitzhak Shamir Medical Center. ( Site 0367)
        • 接触：
          • Study Coordinator
          • 电话号码：972-8-9542196
  • 加拿大
    • Ontario
      • Oshawa、Ontario、加拿大、L1G 2B9
        • 招聘中
        • Lakeridge Health ( Site 0122)
        • 接触：
          • Study Coordinator
          • 电话号码：905-576-8711
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • Princess Margaret Cancer Centre ( Site 0123)
        • 接触：
          • Study Coordinator
          • 电话号码：416-340-4800 x8626
    • Quebec
      • Québec、Quebec、加拿大、G1J 1Z4
        • 招聘中
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)
        • 接触：
          • Study Coordinator
          • 电话号码：4185254444
  • 巴西
      • São Paulo、巴西、01327-001
        • 招聘中
        • Hospital Alemao Oswaldo Cruz ( Site 0101)
        • 接触：
          • Study Coordinator
          • 电话号码：+551135490398
    • Paraná
      • Curitiba、Paraná、巴西、80510-130
        • 招聘中
        • ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)
        • 接触：
          • Study Coordinator
          • 电话号码：+554133361110
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90560-032
        • 招聘中
        • Hospital Moinhos de Vento ( Site 0102)
        • 接触：
          • Study Coordinator
          • 电话号码：+55 51 3314-3209
    • São Paulo
      • São José do Rio Preto、São Paulo、巴西、15090-000
        • 招聘中
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)
        • 接触：
          • Study Coordinator
          • 电话号码：+551732015000
  • 希腊
      • Thessaloniki、希腊、570 01
        • 招聘中
        • European Interbalkan Medical Center ( Site 0331)
        • 接触：
          • Study Coordinator
          • 电话号码：+302310390766
    • Attica
      • Athens、Attica、希腊、145 64
        • 招聘中
        • General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0335)
        • 接触：
          • Study Coordinator
          • 电话号码：+302103501317
      • Athens、Attica、希腊、155 62
        • 招聘中
        • METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)
        • 接触：
          • Study Coordinator
          • 电话号码：+302106502831
      • Chaïdári、Attica、希腊、124 61
        • 招聘中
        • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 0333)
        • 接触：
          • Study Coordinator
          • 电话号码：+302105832549
      • Marousi、Attica、希腊、151 25
        • 招聘中
        • Athens Medical Center ( Site 0336)
        • 接触：
          • Study Coordinator
          • 电话号码：+302106862169
  • 德国
      • Berlin、德国、10117
        • 招聘中
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)
        • 接触：
          • Study Coordinator
          • 电话号码：+49 30 450 615 137
  • 意大利
      • Arezzo、意大利、52100
        • 招聘中
        • Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)
        • 接触：
          • Study Coordinator
          • 电话号码：+390575255446
      • Genova、意大利、16132
        • 招聘中
        • IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)
        • 接触：
          • Study Coordinator
          • 电话号码：+390105553307
      • Milan、意大利、20133
        • 招聘中
        • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)
        • 接触：
          • Study Coordinator
          • 电话号码：+39 02 2390 1
      • Province of Macerata、意大利、62100
        • 招聘中
        • Ospedale Generale Provinciale Macerata ( Site 0395)
        • 接触：
          • Study Coordinator
          • 电话号码：+3907332572881
      • Roma、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)
        • 接触：
          • Study Coordinator
          • 电话号码：+390630154953
    • Milano
      • Rozzano、Milano、意大利、20089
        • 招聘中
        • Istituto Clinico Humanitas ( Site 0398)
        • 接触：
          • Study Coordinator
          • 电话号码：00390282244061
    • Napoli
      • Naples、Napoli、意大利、80131
        • 招聘中
        • Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 0399)
        • 接触：
          • Study Coordinator
          • 电话号码：0817472223
    • Piedmont
      • Orbassano、Piedmont、意大利、10043
        • 招聘中
        • Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391)
        • 接触：
          • Study Coordinator
          • 电话号码：00390119026534
    • Veneto
      • Verona、Veneto、意大利、37134
        • 招聘中
        • Centro Ricerche Cliniche di Verona ( Site 0393)
        • 接触：
          • Study Coordinator
          • 电话号码：+39 045 8126509
  • 日本
      • Fukuoka、日本、812-8582
        • 招聘中
        • Kyushu University Hospital ( Site 0434)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-92-641-1151
      • Gifu、日本、501-1194
        • 招聘中
        • Gifu University Hospital ( Site 0427)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-58-230-6000
      • Kyoto、日本、606-8507
        • 招聘中
        • Kyoto University Hospital ( Site 0433)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-75-751-3111
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、466-8560
        • 招聘中
        • Nagoya University Hospital ( Site 0429)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-52-741-2111
    • Aomori
      • Hirosaki、Aomori、日本、036-8563
        • 招聘中
        • Hirosaki University Hospital ( Site 0435)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-172-33-5111
    • Ehime
      • Tōon、Ehime、日本、791-0295
        • 招聘中
        • Ehime University Hospital ( Site 0430)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-89-964-5111
    • Hokkaido
      • Sapporo、Hokkaido、日本、060-8648
        • 招聘中
        • Hokkaido University Hospital ( Site 0436)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-11-716-1161
    • Hyōgo
      • Kobe、Hyōgo、日本、650-0017
        • 招聘中
        • Kobe University Hospital ( Site 0431)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-78-382-5111
    • Ibaraki
      • Tsukuba、Ibaraki、日本、305-8576
        • 招聘中
        • University of Tsukuba Hospital ( Site 0432)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-29-853-3900
    • Kagawa-ken
      • Kita-gun、Kagawa-ken、日本、761-0793
        • 招聘中
        • Kagawa University Hospital ( Site 0424)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-87-898-5111
    • Kanagawa
      • Kawasaki、Kanagawa、日本、216-8511
        • 招聘中
        • St. Marianna University Hospital ( Site 0422)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-44-977-8111
      • Sagamihara、Kanagawa、日本、252-0375
        • 招聘中
        • Kitasato University Hospital ( Site 0425)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-42-778-8111
    • Nara
      • Kashihara、Nara、日本、634-8522
        • 招聘中
        • Nara Medical University Hospital ( Site 0423)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-744-22-3051
    • Osaka
      • Sakai、Osaka、日本、591-8025
        • 招聘中
        • Osaka Rosai Hospital ( Site 0428)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-72-252-3561
    • Tokyo
      • Bunkyo、Tokyo、日本、113-8519
        • 招聘中
        • Institute of Science Tokyo Hospital ( Site 0421)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-33-813-6111
      • Koto、Tokyo、日本、135-8550
        • 招聘中
        • Cancer Institute Hospital of JFCR ( Site 0426)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-3-3520-0111
  • 比利时
      • Liège、比利时、4000
        • 招聘中
        • CHC Montlegia Clinic ( Site 0061)
        • 接触：
          • Study Coordinator
          • 电话号码：043554213
    • Bruxelles-Capitale, Region de
      • Brussels、Bruxelles-Capitale, Region de、比利时、1200
        • 招聘中
        • Cliniques Universitaires Saint-Luc ( Site 0062)
        • 接触：
          • Study Coordinator
          • 电话号码：+32 2 764 42 95
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、比利时、9000
        • 招聘中
        • AZ Maria Middelares ( Site 0063)
        • 接触：
          • Study Coordinator
          • 电话号码：+3292469522
      • Ghent、Oost-Vlaanderen、比利时、9000
        • 招聘中
        • UZ Gent ( Site 0064)
        • 接触：
          • Study Coordinator
          • 电话号码：+32 9 332 57 93
  • 法国
    • Finistere
      • Brest、Finistere、法国、29200
        • 招聘中
        • CHRU de Brest ( Site 0272)
        • 接触：
          • Study Coordinator
          • 电话号码：+33298223395
    • Ille-et-Vilaine
      • Rennes、Ille-et-Vilaine、法国、35042
        • 招聘中
        • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0280)
        • 接触：
          • Study Coordinator
          • 电话号码：+33299253182
  • 澳大利亚
    • New South Wales
      • Macquarie、New South Wales、澳大利亚、2109
        • 招聘中
        • Macquarie University ( Site 0031)
        • 接触：
          • Study Coordinator
          • 电话号码：+61298505721
    • Queensland
      • South Brisbane、Queensland、澳大利亚、4101
        • 招聘中
        • Mater Hospital Brisbane ( Site 0032)
        • 接触：
          • Study Coordinator
          • 电话号码：+61731637689
  • 瑞典
    • Jönköping County
      • Jönköping、Jönköping County、瑞典、551 85
        • 招聘中
        • Laenssjukhuset Ryhov ( Site 0632)
        • 接触：
          • Study Coordinator
          • 电话号码：+46102410000
    • Stockholm County
      • Stockholm、Stockholm County、瑞典、171 76
        • 招聘中
        • Karolinska Universitetssjukhuset Solna ( Site 0631)
        • 接触：
          • Study Coordinator
          • 电话号码：+46812370000
  • 美国
    • California
      • Newport Beach、California、美国、92658
        • 招聘中
        • Hoag Memorial Hospital Presbyterian ( Site 0814)
        • 接触：
          • Study Coordinator
          • 电话号码：949-764-2704
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20016
        • 招聘中
        • Sibley Memorial Hospital ( Site 0849)
        • 接触：
          • Study Coordinator
          • 电话号码：202-537-4000
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University Hospital ( Site 0824)
        • 接触：
          • Study Coordinator
          • 电话号码：404-778-1900
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 招聘中
        • Johns Hopkins University ( Site 0843)
        • 接触：
          • Study Coordinator
          • 电话号码：240-893-4786
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Dana Farber Cancer Institute ( Site 0783)
        • 接触：
          • Study Coordinator
          • 电话号码：617-632-3466
    • Michigan
      • Traverse City、Michigan、美国、49684
        • 招聘中
        • Munson Medical Center ( Site 0812)
        • 接触：
          • Study Coordinator
          • 电话号码：231-392-8400
    • New Jersey
      • Morristown、New Jersey、美国、07960
        • 招聘中
        • Morristown Memorial Hospital ( Site 0795)
        • 接触：
          • Study Coordinator
          • 电话号码：937-917-5000
    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center ( Site 0832)
        • 接触：
          • Study Coordinator
          • 电话号码：347-798-9213
    • North Carolina
      • Raleigh、North Carolina、美国、27610
        • 招聘中
        • WakeMed Raleigh Campus ( Site 0811)
        • 接触：
          • Study Coordinator
          • 电话号码：919-350-8585
    • Ohio
      • Cincinnati、Ohio、美国、45220
        • 招聘中
        • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)
        • 接触：
          • Study Coordinator
          • 电话号码：513-865-5249
      • Cleveland、Ohio、美国、44106
        • 招聘中
        • University Hospitals of Cleveland Case Medical Center ( Site 0834)
        • 接触：
          • Study Coordinator
          • 电话号码：216-844-6031
      • Cleveland、Ohio、美国、44195
        • 招聘中
        • Cleveland Clinic - Ohio ( Site 0793)
        • 接触：
          • Study Coordinator
          • 电话号码：866-233-8100
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • 招聘中
        • Fox Chase Cancer Center ( Site 0830)
        • 接触：
          • Study Coordinator
          • 电话号码：888-369-2427
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • 招聘中
        • The West Clinic, P.C. ( Site 0791)
        • 接触：
          • Study Coordinator
          • 电话号码：901-683-0055
      • Knoxville、Tennessee、美国、37916
        • 招聘中
        • Thompson Cancer Survival Center ( Site 0803)
        • 接触：
          • Study Coordinator
          • 电话号码：865-331-1720
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)
        • 接触：
          • Study Coordinator
          • 电话号码：877-836-6662
    • Utah
      • Salt Lake City、Utah、美国、84112
        • 招聘中
        • University of Utah, Huntsman Cancer Institute ( Site 0810)
        • 接触：
          • Study Coordinator
          • 电话号码：801-587-7000
    • Virginia
      • Norfolk、Virginia、美国、23502
        • 招聘中
        • Virginia Oncology Associates (VOA) ( Site 8002)
        • 接触：
          • Study Coordinator
          • 电话号码：757-466-8663
    • Washington
      • Seattle、Washington、美国、98109
        • 招聘中
        • Fred Hutchinson Cancer Research Center ( Site 0787)
        • 接触：
          • Study Coordinator
          • 电话号码：206-606-1943
  • 英国
    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 0QQ
        • 招聘中
        • Cambridge University Hospitals NHS Foundation Trust ( Site 0756)
        • 接触：
          • Study Coordinator
          • 电话号码：01223 216083
    • London, City of
      • London、London, City of、英国、EC1A 7BE
        • 招聘中
        • St Bartholomew's Hospital ( Site 0751)
        • 接触：
          • Study Coordinator
          • 电话号码：07437894656
  • 荷兰
      • Utrecht、荷兰、3543 AZ
        • 招聘中
        • St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)
        • 接触：
          • Study Coordinator
          • 电话号码：+31883205148
    • Gelderland
      • Nijmegen、Gelderland、荷兰、6525 GA
        • 招聘中
        • Radboudumc ( Site 0487)
        • 接触：
          • Study Coordinator
          • 电话号码：+31243610353
    • Limburg
      • Maastricht、Limburg、荷兰、6229 HX
        • 招聘中
        • Maastricht UMC+ ( Site 0483)
        • 接触：
          • Study Coordinator
          • 电话号码：+31433877025
    • North Holland
      • Amsterdam、North Holland、荷兰、1066 CX
        • 招聘中
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)
        • 接触：
          • Study Coordinator
          • 电话号码：+31205129111
      • Tilburg、North Holland、荷兰、5022 GC
        • 招聘中
        • Elisabeth-TweeSteden Ziekenhuis ( Site 0489)
        • 接触：
          • Study Coordinator
          • 电话号码：+31132210420
    • Overijssel
      • Zwolle、Overijssel、荷兰、8025 AB
        • 招聘中
        • Isala, locatie Zwolle ( Site 0486)
        • 接触：
          • Study Coordinator
          • 电话号码：+31886247573
    • South Holland
      • Rotterdam、South Holland、荷兰、3015 GD
        • 招聘中
        • Erasmus Medisch Centrum ( Site 0481)
        • 接触：
          • Study Coordinator
          • 电话号码：+31107040252
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall d Hebron ( Site 0607)
        • 接触：
          • Study Coordinator
          • 电话号码：+34934893000
      • Madrid、西班牙、28040
        • 招聘中
        • Hospital Clinico San Carlos ( Site 0608)
        • 接触：
          • Study Coordinator
          • 电话号码：913303000
      • Madrid、西班牙、28041
        • 招聘中
        • Hospital Universitario 12 de Octubre ( Site 0602)
        • 接触：
          • Study Coordinator
          • 电话号码：+34 913 908 307
      • Seville、西班牙、41013
        • 招聘中
        • Hospital Virgen del Rocio ( Site 0601)
        • 接触：
          • Study Coordinator
          • 电话号码：+34 95 501 30 68
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • 招聘中
        • H. de Badalona Germans Trias I Pujol ( Site 0603)
        • 接触：
          • Study Coordinator
          • 电话号码：93 497 89 25
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • 招聘中
        • Hospital Universitario Marques de Valdecilla ( Site 0605)
        • 接触：
          • Study Coordinator
          • 电话号码：+34 942 20 25 25
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35016
        • 招聘中
        • Hospital Universitario Insular de Gran Canaria ( Site 0604)
        • 接触：
          • Study Coordinator
          • 电话号码：+34 92 844 17 38
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28034
        • 招聘中
        • Hospital Universitario Ramon y Cajal ( Site 0606)
        • 接触：
          • Study Coordinator
          • 电话号码：+34913368263
  • 阿根廷
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1419AHN
        • 招聘中
        • Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)
        • 接触：
          • Study Coordinator
          • 电话号码：01145744343
      • Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1199ABD
        • 招聘中
        • Hospital Italiano de Buenos Aires ( Site 0004)
        • 接触：
          • Study Coordinator
          • 电话号码：+5491155933332
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、C1426ANZ
        • 招聘中
        • Instituto Alexander Fleming ( Site 0002)
        • 接触：
          • Study Coordinator
          • 电话号码：+541132218900
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、S2000KZE
        • 招聘中
        • Instituto de Oncologia de Rosario ( Site 0005)
        • 接触：
          • Study Coordinator
          • 电话号码：0341156602277

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.
生物：Sacituzumab tirumotecan

IV infusion

其他名称：
  • SKB264
  • MK-2870
  • 囊TMT
药品：Rescue medications for sacituzumab tirumotecan

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).
有源比较器：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.
药品：Paclitaxel

IV infusion

药品：Docetaxel

IV infusion

药品：Vinflunine

IV infusion

药品：Rescue medications for chemotherapy

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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to approximately 40 months

OS is defined as time from randomization to death due to any cause.
Up to approximately 40 months

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月23日

初级完成 (估计的)

2029年7月27日

研究完成 (估计的)

2030年4月23日

研究注册日期

首次提交

2026年2月10日

首先提交符合 QC 标准的

2026年2月10日

首次发布 (实际的)

2026年2月19日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2870-031
  • U1111-1316-4390 (注册表标识符：UTN)
  • 2024-520014-22-00 (注册表标识符：EU CT)
  • MK-2870-031 (其他标识符：MSD)
  • jRCT2051260020 (注册表标识符：Japan Registry of Clinical Trial (jRCT))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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