Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (TroFuse-005)

A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)

Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: Doxorubicin; Drug: Paclitaxel; Biological: Sacituzumab tirumotecan; Drug: Nab-paclitaxel; Drug: Rescue medications

• Study Type: Interventional
• Enrollment (Estimated): 710
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman-Oncology ( Site 1001)
  • Buenos Aires, Argentina, C1417DTB
    • Instituto de Oncología Angel H. Roffo ( Site 1003)
  • Buenos Aires, Argentina, C1431FWO
    • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)
  • La Rioja, Argentina, F5300COE
    • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
      • Hospital Británico de Buenos Aires-Oncology ( Site 1002)
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1122AAL
      • Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)
    • Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
      • Instituto Alexander Fleming-Alexander Fleming ( Site 1007)
• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare North Shore ( Site 1103)
    • Sydney, New South Wales, Australia, 2148
      • Blacktown Hospital ( Site 1101)
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital ( Site 1102)
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Epworth Freemasons ( Site 1104)
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital ( Site 1105)
• Austria
  • Vienna, Austria, 1090
    • Medizinische Universität Wien ( Site 1202)
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201)
• Belgium
  • Namur, Belgium, 5000
    • CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304)
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares-IKG ( Site 1305)
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent-Medical oncology ( Site 1303)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven-Gynecologic Oncology ( Site 1301)
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ Delta vzw-Oncology ( Site 1302)
• Brazil
  • Rio de Janeiro, Brazil, 20775-001
    • Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352)
  • São Paulo, Brazil, 01232-010
    • Hospital Samaritano De Sao Paulo ( Site 1367)
  • São Paulo, Brazil, 01509-010
    • A. C. Camargo Cancer Center ( Site 1351)
  • São Paulo, Brazil, 04014-002
    • IBCC - Núcleo de Pesquisa e Ensino ( Site 1366)
  • Maranhão
    • São Luís, Maranhão, Brazil, 65060-645
      • Hospital São Domingos ( Site 1365)
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38408-150
      • Centro Oncologico do Triangulo ( Site 1360)
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
      • Hospital Moinhos de Vento ( Site 1359)
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89201260
      • Instituto Joinvilense de Hematologia e Oncologia ( Site 1353)
  • São Paulo
    • Sorocaba, São Paulo, Brazil, 18052-775
      • Instituto de Ensino e Pesquisa ( Site 1355)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute ( Site 1414)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Vancouver ( Site 1415)
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2N1
      • Trillium Health Partners - Credit Valley Hospital ( Site 1410)
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408)
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405)
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal ( Site 1403)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 1404)
• Chile
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500653
      • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505)
    • Santiago, Region M. de Santiago, Chile, 8330024
      • Pontificia Universidad Catolica de Chile ( Site 1503)
    • Santiago, Region M. de Santiago, Chile, 8420383
      • Bradfordhill-Clinical Area ( Site 1501)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4800827
      • James Lind Centro de Investigacion del Cancer ( Site 1504)
• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100006
      • Beijing Obstetric and Gynecology Hospital ( Site 1653)
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627)
    • Xiamen, Fujian, China, 361003
      • The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613)
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634)
    • Guangzhou, Guangdong, China, 510555
      • Sun Yat-sen University Cancer Center ( Site 1604)
    • Shantou, Guangdong, China, 515041
      • Cancer Hospital of Shantou University Medical College ( Site 1642)
    • Zhanjiang, Guangdong, China, 524004
      • Affiliated Hospital of Guangdong Medical University ( Site 1614)
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622)
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital ( Site 1636)
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652)
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital ( Site 1618)
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University ( Site 1640)
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621)
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607)
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University-Gynecology ( Site 1603)
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital ( Site 1623)
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital ( Site 1649)
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 1625)
  • Shandong
    • Linyi, Shandong, China, 276000
      • LinYi Cancer Hospital-Gastrology department ( Site 1630)
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Obstetrics & Gynecology Hospital of Fudan University ( Site 1617)
    • Shanghai, Shanghai Municipality, China, 201204
      • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1626)
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Second University Hospital, Sichuan University ( Site 1602)
    • Chengdu, Sichuan, China, 610042
      • Sichuan Cancer hospital-Oncology ( Site 1650)
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 1648)
  • Yunnan
    • Kunming, Yunnan, China, 650107
      • Yunnan Province Cancer Hospital-Gynecology Department ( Site 1641)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 1609)
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital-Oncology ( Site 1601)
    • Linhai, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province ( Site 1633)
    • Wenzhou, Zhejiang, China, 325015
      • The First Affiliated Hospital of Wenzhou Medical University ( Site 1615)
• Czechia
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 602 00
      • Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704)
  • Moravskoslezský kraj
    • Ostrava, Moravskoslezský kraj, Czechia, 708 52
      • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703)
  • Novy Jicin
    • Nový Jiín, Novy Jicin, Czechia, 741 01
      • Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706)
  • Olomoucký kraj
    • Olomouc, Olomoucký kraj, Czechia, 779 00
      • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702)
  • Praha 10
    • Prague, Praha 10, Czechia, 100 34
      • Fakultni nemocnice Kralovske Vinohrady ( Site 1707)
  • Praha 2
    • Prague, Praha 2, Czechia, 12808
      • Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1705)
  • Praha 8
    • Prague, Praha 8, Czechia, 180 00
      • Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701)
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2730
      • Herlev and Gentofte Hospital-Department of Oncology ( Site 1801)
    • Copenhagen, Capital Region, Denmark, DK-2100
      • Rigshospitalet-Dept. of Oncology ( Site 1803)
  • Central Jutland
    • Aarhus, Central Jutland, Denmark, 8200
      • Aarhus Universitetshospital, Skejby ( Site 1802)
• Finland
  • Northern Savonia
    • Kuopio, Northern Savonia, Finland, 70210
      • Kuopion Yliopistollinen Sairaala ( Site 1904)
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33520
      • Tampereen yliopistollinen sairaala ( Site 1901)
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903)
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902)
• France
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005)
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33076
      • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002)
  • Auvergne-Rhône-Alpes
    • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
      • CENTRE LEON BERARD ( Site 2004)
  • Centre-Val de Loire
    • Chambray-lès-Tours, Centre-Val de Loire, France, 37170
      • ROC37 ( Site 2010)
  • Cotes-d Armor
    • Plérin, Cotes-d Armor, France, 22190
      • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 2001)
  • Doubs
    • Besançon, Doubs, France, 25000
      • CHU Besançon ( Site 2009)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Institut Claudius Regaud ( Site 2006)
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59020
      • Centre Oscar Lambret ( Site 2007)
  • Herault
    • Montpellier, Herault, France, 34298
      • Institut Regional du Cancer Montpellier ( Site 2008)
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35042
      • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003)
• Germany
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum ( Site 2102)
  • Baden-Wurttemberg
    • Heilbronn, Baden-Wurttemberg, Germany, 74078
      • SLK-Kliniken Heilbronn ( Site 2107)
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 2101)
    • Ravensburg, Baden-Wurttemberg, Germany, 88212
      • MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum ( Site 2110)
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen ( Site 2111)
  • Bavaria
    • Munich, Bavaria, Germany, 81337
      • Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 2109)
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45136
      • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2104)
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 2103)
• Greece
  • Achaia
    • Pátrai, Achaia, Greece, 263 35
      • Agios Andreas Hospital Patras ( Site 2201)
  • Attica
    • Athens, Attica, Greece, 115 28
      • Aretaieio Hospital Oncology Unit ( Site 2206)
    • Athens, Attica, Greece, 185 47
      • Metropolitan Hospital-2nd Oncology Dept ( Site 2202)
    • Marousi, Attica, Greece, 151 23
      • Hygeia Hospital ( Site 2204)
• Ireland
  • Cork, Ireland, T12 DC4A
    • Cork University Hospital ( Site 2402)
  • Dublin, Ireland, D07 R2WY
    • Mater Misericordiae University Hospital ( Site 2403)
  • Dublin, Ireland, D08 E9P6
    • St. James's Hospital-Cancer clinical trials office ( Site 2401)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502)
  • Holon, Israel, 5810001
    • Edith Wolfson Medical Center ( Site 2501)
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center ( Site 2503)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 2505)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 2504)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 2506)
• Italy
  • Bari, Italy, 70124
    • Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 2604)
  • Brescia, Italy, 25123
    • Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611)
  • Milan, Italy, 20159
    • Humanitas San Pio X Hospital ( Site 2614)
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2602)
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova ( Site 2612)
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601)
  • Torino, Italy, 10128
    • Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608)
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 2603)
  • Friuli Venezia Giulia
    • Aviano, Friuli Venezia Giulia, Italy, 33081
      • CRO-IRCCS ( Site 2609)
  • Lazio
    • Rome, Lazio, Italy, 00161
      • AOU Policlinico Umberto I ( Site 2606)
  • Lombardy
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2605)
    • Milan, Lombardy, Italy, 20141
      • Istituto Europeo di Oncologia IRCCS ( Site 2607)
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610)
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'O-Day Hospital Oncologico Multidisciplin ( Site 2613)
• Japan
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center ( Site 2711)
  • Kagoshima, Japan, 890-8760
    • Kagoshima City Hospital ( Site 2717)
  • Osaka, Japan, 541-8567
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2718)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center ( Site 2714)
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center ( Site 2705)
    • Tōon, Ehime, Japan, 791-0295
      • Ehime University Hospital ( Site 2709)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 2703)
  • Gunma
    • Otashi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center ( Site 2708)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital ( Site 2707)
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital ( Site 2713)
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital ( Site 2712)
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital ( Site 2701)
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center ( Site 2710)
  • Shizuoka
    • Sunto-gun,, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center ( Site 2716)
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital ( Site 2715)
    • Koto, Tokyo, Japan, 135-8550
      • Cancer Institute Hospital of JFCR ( Site 2706)
    • Shinagawa, Tokyo, Japan, 142-8666
      • Showa Medical University Hospital ( Site 2719)
    • Shinjuku, Tokyo, Japan, 160-8582
      • Keio University Hospital ( Site 2702)
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803)
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre ( Site 2801)
• Mexico
  • Mexico City
    • Coyoacán, Mexico City, Mexico, 04700
      • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902)
    • Mexico City, Mexico City, Mexico, 11819
      • Higiea Oncologia ( Site 2905)
  • Nuevo León
    • San Pedro Garza García, Nuevo León, Mexico, 66220
      • Oncare - Unidad Valle ( Site 2906)
    • San Pedro Garza García, Nuevo León, Mexico, 66278
      • CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 2901)
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68020
      • Centro de Investigacion Clinica de Oaxaca ( Site 2907)
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboudumc-Medical Oncology ( Site 3003)
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081 HV
      • Amsterdam UMC - locatie VUmc ( Site 3004)
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 ZA
      • Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002)
• Norway
  • Oslo, Norway, 0379
    • Oslo universitetssykehus, Radiumhospitalet ( Site 3102)
  • Rogaland
    • Stavanger, Rogaland, Norway, 4011
      • Stavanger Universitetssykehus ( Site 3103)
  • Troms
    • Tromsø, Troms, Norway, 9038
      • Universitetssykehuset Nord-Norge HF ( Site 3101)
  • Vest-Agder
    • Kristiansand, Vest-Agder, Norway, 4615
      • Sorlandet Sykehus Kristiansand ( Site 3104)
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-866
      • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek ( Site 3202)
  • Masovian Voivodeship
    • Siedlce, Masovian Voivodeship, Poland, 08-110
      • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201)
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 3203)
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-027
      • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204)
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Ad-Vance Medical Research-Research ( Site 3302)
  • San Juan, Puerto Rico, 00909
    • Pan American Center for Oncology Trials - Ciudadela ( Site 3301)
  • San Juan, Puerto Rico, 00935
    • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 168583
      • National Cancer Centre Singapore-Medical Oncology ( Site 3401)
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 3502)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503)
  • Seoul, South Korea, 05505
    • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501)
  • Seoul, South Korea, 06351
    • Samsung Medical Center ( Site 3504)
  • Kyonggi-do
    • Seongnam, Kyonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602)
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601)
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608)
  • Gerona
    • Girona, Gerona, Spain, 17007
      • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 3606)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28027
      • Clinica Universidad de Navarra ( Site 3603)
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607)
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Hospital Universitario La Paz-Oncología Médica ( Site 3604)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46009
      • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605)
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • HOSPITAL CLINICO DE VALENCIA ( Site 3609)
• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 22185
      • Skånes Universitetssjukhus Lund ( Site 3702)
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Karolinska Universitetssjukhuset Solna ( Site 3701)
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern-Oncology ( Site 3801)
  • Canton Ticino
    • Bellinzona, Canton Ticino, Switzerland, 6500
      • Ospedale Regionale Bellinzona e Valli ( Site 3802)
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 3808)
  • Kanton Graubünden
    • Chur, Kanton Graubünden, Switzerland, 7000
      • Kantonsspital Graubünden-Medizin ( Site 3803)
• United Kingdom
  • Manchester, United Kingdom, m20 4bx
    • The Christie NHS Foundation Trust-Medical Oncology ( Site 4003)
  • Brighton And Hove
    • East Sussex, Brighton And Hove, United Kingdom, BN2 1ES
      • University Hospitals Sussex NHS Foundation Trust ( Site 4006)
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Royal Derby Hospital ( Site 4007)
  • England
    • London, England, United Kingdom, SW3 6JJ
      • ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002)
    • Truro, England, United Kingdom, TR1 3LJ
      • The Royal Cornwall Hospital ( Site 4009)
  • London, City of
    • London, London, City of, United Kingdom, NW1 2PG
      • University College London Hospital-Cancer Clinical Trials Unit ( Site 4004)
    • London, London, City of, United Kingdom, SE1 9RT
      • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 4008)
    • London, London, City of, United Kingdom, W12 OHS
      • Hammersmith Hospital ( Site 4001)
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0YN
      • The Beatson West of Scotland Cancer Centre ( Site 4005)
  • Sutton
    • London, Sutton, United Kingdom, SW3 6JJ
      • Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010)
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • USA Mitchell Cancer Institute ( Site 4142)
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Womens Cancer Care ( Site 4122)
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • HonorHealth (HH) ( Site 8000)
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates - HOPE ( Site 8002)
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus ( Site 4129)
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center ( Site 4108)
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Cancer Center ( Site 4117)
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists - East ( Site 7000)
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital ( Site 4112)
    • Augusta, Georgia, United States, 30912
      • Augusta University ( Site 4116)
    • Columbus, Georgia, United States, 31904
      • Centricity Research Columbus Cancer Center ( Site 4154)
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital ( Site 4110)
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center at Parkview Regional Medical Center ( Site 4132)
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans ( Site 4133)
    • Shreveport, Louisiana, United States, 71103
      • TRIALS 365 ( Site 4105)
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Memorial Medical Center ( Site 4103)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)
  • Nevada
    • Reno, Nevada, United States, 89511
      • The Center of Hope ( Site 4109)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Morristown Medical Center ( Site 4135)
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center ( Site 4115)
  • New York
    • Brooklyn, New York, United States, 11215
      • New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center ( Site 4106)
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)
    • West Islip, New York, United States, 11795
      • Good Samaritan Hospital Medical Center ( Site 4139)
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute ( Site 4120)
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Sanford Health Roger Maris Cancer Center ( Site 4158)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center ( Site 4136)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)
    • Pittsburgh, Pennsylvania, United States, 15244
      • AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)
    • Willow Grove, Pennsylvania, United States, 19090
      • Asplundh Cancer Pavilion ( Site 4107)
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital ( Site 4138)
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center-Gynecologic Oncology ( Site 4121)
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic, PLLC dba West Cancer Center ( Site 4102)
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio ( Site 8005)
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - Gulf Coast ( Site 8006)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
• Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
• Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Exclusion Criteria:

• Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
• Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
• Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
• Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
• Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
• Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
• Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
• Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
• Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemotherapy; Participants will receive 60 mg/m^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel.	Drug: Doxorubicin; 60 mg/m^2 of doxorubicin by IV Infusion; Other Names: ADRIAMYCIN®; Drug: Paclitaxel; 80 mg/m^2 of paclitaxel by IV infusion; Other Names: TAXOL®; Drug: Nab-paclitaxel; 100 mg/m^2 of nab-paclitaxel by IV infusion; Other Names: Abraxane
Experimental: Sacituzumab tirumotecan; Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle.	Biological: Sacituzumab tirumotecan; 4 mg/kg of sacituzumab tirumotecan by IV infusion; Other Names: SKB264 MK-2870; Drug: Rescue medications; Participants will receive the following rescue medications per approved product label before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 48 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.	Up to approximately 27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR	ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR.	Up to approximately 27 months
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.	Up to approximately 27 months
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is defined as 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.	Up to approximately 48 months
Number of Participants Who Discontinue Study Intervention Due to an AE	An AE is defined as 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.	Up to approximately 48 months
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30])	The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.	Baseline, up to approximately 48 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: GOG Foundation; European Network for Gynaecological Oncological Trial groups(ENGOT)
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): January 10, 2028

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Endometrial cancer; Antibody-drug conjugate (ADC); Trophoblast cell-surface antigen 2 (TROP2)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Taxoids; Cyclodecanes; Diterpenes; Anthracyclines; Naphthacenes; Aminoglycosides; Daunorubicin; Albumins; Albumin-Bound Paclitaxel; Doxorubicin; Paclitaxel; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: 2870-005; U1111-1288-7581 (Registry Identifier: UTN); jRCT2031240041 (Registry Identifier: Japan Registry of Clinical Trials (jRCT)); 2023-504816-14-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No