AzTrials
AzTrials

Endometrial CancerPhase 3TroFuse-005NCT06132958

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

A Phase 3 study testing Sacituzumab tirumotecan, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC at 242 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Sacituzumab tirumotecan, Doxorubicin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
242 sitesin 31 countries
Study dates
6 Dec 2023to 10 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

242 sites in 31 countries.

242 sites in 31 countries

United States43 sites

  • Alaska Womens Cancer Care ( Site 4122)

    Anchorage, Alaska, 99508

  • Northside Hospital ( Site 4112)

    Atlanta, Georgia, 30342

  • Augusta University ( Site 4116)

    Augusta, Georgia, 30912

  • New York - Presbyterian Brooklyn Methodist Hospital ( Site 4134)

    Brooklyn, New York, 11215

  • University of Cincinnati Medical Center ( Site 4136)

    Cincinnati, Ohio, 45219

  • Centricity Research Columbus Cancer Center ( Site 4154)

    Columbus, Georgia, 31904

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C (Site 4125)

    Columbus, Ohio, 43210

  • Duke Cancer Institute ( Site 4120)

    Durham, North Carolina, 27710

  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 4150)

    Edgewood, Kentucky, 41017

  • NorthShore University HealthSystem - Evanston Hospital ( Site 4110)

    Evanston, Illinois, 60201

  • Sanford Health Roger Maris Cancer Center ( Site 4158)

    Fargo, North Dakota, 58102

  • Parkview Research Center at Parkview Regional Medical Center ( Site 4132)

    Fort Wayne, Indiana, 46845

  • The West Clinic, PLLC dba West Cancer Center ( Site 4102)

    Germantown, Tennessee, 38138

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 4118)

    Hackensack, New Jersey, 07601

  • Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130)

    Houston, Texas, 77030

  • UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)

    Los Angeles, California, 90095

  • Mount Sinai Cancer Center ( Site 4117)

    Miami Beach, Florida, 33140

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156)

    Mineola, New York, 11501

  • USA Mitchell Cancer Institute ( Site 4142)

    Mobile, Alabama, 36604

  • Atlantic Health System Morristown Medical Center ( Site 4135)

    Morristown, New Jersey, 07960

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)

    New Haven, Connecticut, 06511

  • University Medical Center New Orleans ( Site 4133)

    New Orleans, Louisiana, 70112

  • Laura and Isaac Perlmutter Cancer Center ( Site 4106)

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai-Department of Obstetrics, Gynecology, and Reproductive Scie ( Site 4128)

    New York, New York, 10029

  • AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)

    Orlando, Florida, 32804

  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 4157)

    Philadelphia, Pennsylvania, 19107

  • HonorHealth (HH) ( Site 8000)

    Phoenix, Arizona, 85016

  • AHN West Penn Hospital-Gynecologic Oncology ( Site 4111)

    Pittsburgh, Pennsylvania, 15244

  • Women & Infants Hospital ( Site 4138)

    Providence, Rhode Island, 02905

  • The Center of Hope ( Site 4109)

    Reno, Nevada, 89511

  • Texas Oncology - San Antonio ( Site 8005)

    San Antonio, Texas, 78240

  • California Pacific Medical Center - Van Ness Campus ( Site 4129)

    San Francisco, California, 94109

  • TRIALS 365 ( Site 4105)

    Shreveport, Louisiana, 71103

  • Sanford Cancer Center-Gynecologic Oncology ( Site 4121)

    Sioux Falls, South Dakota, 57104

  • Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146)

    St Louis, Missouri, 63110

  • Holy Name Medical Center ( Site 4115)

    Teaneck, New Jersey, 07666

  • Texas Oncology - Gulf Coast ( Site 8006)

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates - HOPE ( Site 8002)

    Tucson, Arizona, 85711

  • MedStar Washington Hospital Center ( Site 4108)

    Washington D.C., District of Columbia, 20010

  • Good Samaritan Hospital Medical Center ( Site 4139)

    West Islip, New York, 11795

  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida, 33401

  • Asplundh Cancer Pavilion ( Site 4107)

    Willow Grove, Pennsylvania, 19090

  • University of Massachusetts Memorial Medical Center ( Site 4103)

    Worcester, Massachusetts, 01605

Other trials in United States

China30 sites

  • Beijing Obstetric and Gynecology Hospital ( Site 1653)

    Beijing, Beijing Municipality, 100006

  • Xiangya Hospital Central South University-Gynecology ( Site 1603)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 1623)

    Changsha, Hunan, 410013

  • West China Second University Hospital, Sichuan University ( Site 1602)

    Chengdu, Sichuan, 610000

  • Sichuan Cancer hospital-Oncology ( Site 1650)

    Chengdu, Sichuan, 610042

  • Fujian Cancer Hospital-Gynecological Oncology Surgery ( Site 1627)

    Fuzhou, Fujian, 350014

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1634)

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen University Cancer Center ( Site 1604)

    Guangzhou, Guangdong, 510555

  • Hainan General Hospital ( Site 1636)

    Haikou, Hainan, 570311

  • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 1609)

    Hangzhou, Zhejiang, 310006

  • Zhejiang Cancer Hospital-Oncology ( Site 1601)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital-Gynecological Radiotherapy Department ( Site 1652)

    Harbin, Heilongjiang, 150000

  • Second Affiliated hospital of Anhui Medical University-Oncology ( Site 1635)

    Hefei, Anhui, 230000

  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 1641)

    Kunming, Yunnan, 650107

  • Taizhou Hospital of Zhejiang Province ( Site 1633)

    Linhai, Zhejiang, 317000

  • LinYi Cancer Hospital-Gastrology department ( Site 1630)

    Linyi, Shandong, 276000

  • Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 1625)

    Nanchang, Jiangxi, 330000

  • Nanjing First Hospital ( Site 1649)

    Nanjing, Jiangsu, 210006

  • Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 1622)

    Nanning, Guangxi, 530021

  • Obstetrics & Gynecology Hospital of Fudan University ( Site 1617)

    Shanghai, Shanghai Municipality, 200011

  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1626)

    Shanghai, Shanghai Municipality, 201204

  • Cancer Hospital of Shantou University Medical College ( Site 1642)

    Shantou, Guangdong, 515041

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 1648)

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 1615)

    Wenzhou, Zhejiang, 325015

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1621)

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 1607)

    Wuhan, Hubei, 430079

  • The First Affiliated hospital of Xiamen University-Obstetrics and gynecology department ( Site 1613)

    Xiamen, Fujian, 361003

  • Affiliated Hospital of Guangdong Medical University ( Site 1614)

    Zhanjiang, Guangdong, 524004

  • Henan Cancer Hospital ( Site 1618)

    Zhengzhou, Henan, 450008

  • The Second Affiliated Hospital of Zhengzhou University ( Site 1640)

    Zhengzhou, Henan, 450014

Other trials in China

Japan18 sites

  • National Cancer Center Hospital ( Site 2715)

    Chuo-ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center ( Site 2711)

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center ( Site 2710)

    Hidaka, Saitama, 350-1298

  • Kagoshima City Hospital ( Site 2717)

    Kagoshima, 890-8760

  • Cancer Institute Hospital of JFCR ( Site 2706)

    Koto, Tokyo, 135-8550

  • Kurume University Hospital ( Site 2703)

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Shikoku Cancer Center ( Site 2705)

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center ( Site 2714)

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital ( Site 2701)

    Niigata, Niigata, 951-8566

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2718)

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center ( Site 2708)

    Otashi, Gunma, 373-8550

  • Hokkaido University Hospital ( Site 2707)

    Sapporo, Hokkaido, 060-8648

  • Showa Medical University Hospital ( Site 2719)

    Shinagawa, Tokyo, 142-8666

  • Keio University Hospital ( Site 2702)

    Shinjuku, Tokyo, 160-8582

  • Iwate Medical University Hospital ( Site 2712)

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center ( Site 2716)

    Sunto-gun,, Shizuoka, 411-8777

  • Ehime University Hospital ( Site 2709)

    Tōon, Ehime, 791-0295

  • University of Tsukuba Hospital ( Site 2713)

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

Italy14 sites

  • CRO-IRCCS ( Site 2609)

    Aviano, Friuli Venezia Giulia, 33081

  • Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 2604)

    Bari, 70124

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlin-SSD Oncologia medica Addarii ( Site 2603)

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611)

    Brescia, 25123

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'O-Day Hospital Oncologico Multidisciplin ( Site 2613)

    Candiolo, Torino, 10060

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 2605)

    Milan, Lombardy, 20133

  • Istituto Europeo di Oncologia IRCCS ( Site 2607)

    Milan, Lombardy, 20141

  • Humanitas San Pio X Hospital ( Site 2614)

    Milan, 20159

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2602)

    Naples, 80131

  • Arcispedale Santa Maria Nuova ( Site 2612)

    Reggio Emilia, 42123

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601)

    Roma, 00168

  • AOU Policlinico Umberto I ( Site 2606)

    Rome, Lazio, 00161

  • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610)

    Rozzano, Milano, 20089

  • Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608)

    Torino, 10128

Other trials in Italy

France10 sites

  • CHU Besançon ( Site 2009)

    Besançon, Doubs, 25000

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 2002)

    Bordeaux, Aquitaine, 33076

  • ROC37 ( Site 2010)

    Chambray-lès-Tours, Centre-Val de Loire, 37170

  • Centre Oscar Lambret ( Site 2007)

    Lille, Hauts-de-France, 59020

  • CENTRE LEON BERARD ( Site 2004)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

  • Institut Regional du Cancer Montpellier ( Site 2008)

    Montpellier, Herault, 34298

  • Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005)

    Paris, 75020

  • Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 2001)

    Plérin, Cotes-d Armor, 22190

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003)

    Rennes, Ille-et-Vilaine, 35042

  • Institut Claudius Regaud ( Site 2006)

    Toulouse, Haute-Garonne, 31059

Other trials in France

United Kingdom10 sites

  • Royal Derby Hospital ( Site 4007)

    Derby, Derbyshire, DE22 3NE

  • University Hospitals Sussex NHS Foundation Trust ( Site 4006)

    East Sussex, Brighton And Hove, BN2 1ES

  • The Beatson West of Scotland Cancer Centre ( Site 4005)

    Glasgow, Scotland, G12 0YN

  • ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002)

    London, England, SW3 6JJ

  • University College London Hospital-Cancer Clinical Trials Unit ( Site 4004)

    London, London, City of, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 4008)

    London, London, City of, SE1 9RT

  • Hammersmith Hospital ( Site 4001)

    London, London, City of, W12 OHS

  • Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010)

    London, Sutton, SW3 6JJ

  • The Christie NHS Foundation Trust-Medical Oncology ( Site 4003)

    Manchester, m20 4bx

  • The Royal Cornwall Hospital ( Site 4009)

    Truro, England, TR1 3LJ

Other trials in United Kingdom

Brazil9 sites

  • Instituto Joinvilense de Hematologia e Oncologia ( Site 1353)

    Joinville, Santa Catarina, 89201260

  • Hospital Moinhos de Vento ( Site 1359)

    Porto Alegre, Rio Grande do Sul, 90560-032

  • Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 1352)

    Rio de Janeiro, 20775-001

  • Hospital São Domingos ( Site 1365)

    São Luís, Maranhão, 65060-645

  • Hospital Samaritano De Sao Paulo ( Site 1367)

    São Paulo, 01232-010

  • A. C. Camargo Cancer Center ( Site 1351)

    São Paulo, 01509-010

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 1366)

    São Paulo, 04014-002

  • Instituto de Ensino e Pesquisa ( Site 1355)

    Sorocaba, São Paulo, 18052-775

  • Centro Oncologico do Triangulo ( Site 1360)

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Spain9 sites

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602)

    Barcelona, 08035

  • Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601)

    Córdoba, 14004

  • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 3606)

    Girona, Gerona, 17007

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Clinica Universidad de Navarra ( Site 3603)

    Madrid, Madrid, Comunidad de, 28027

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607)

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario La Paz-Oncología Médica ( Site 3604)

    Madrid, Madrid, Comunidad de, 28046

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605)

    Valencia, Valenciana, Comunitat, 46009

  • HOSPITAL CLINICO DE VALENCIA ( Site 3609)

    Valencia, Valenciana, Comunitat, 46010

Other trials in Spain

Canada8 sites

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 1413)

    Calgary, Alberta, T2N 5G2

  • CIUSSS- saguenay-Lac-Saint-Jean ( Site 1408)

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute ( Site 1414)

    Edmonton, Alberta, T6G 1Z2

  • Trillium Health Partners - Credit Valley Hospital ( Site 1410)

    Mississauga, Ontario, L5M 2N1

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 1405)

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Université de Montréal ( Site 1403)

    Montreal, Quebec, H2X 0C1

  • McGill University Health Centre ( Site 1404)

    Montreal, Quebec, H4A 3J1

  • BC Cancer Vancouver ( Site 1415)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany8 sites

  • Charité Campus Virchow-Klinikum ( Site 2102)

    Berlin, 13353

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur ( Site 2103)

    Dresden, Saxony, 01307

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2104)

    Essen, North Rhine-Westphalia, 45136

  • SLK-Kliniken Heilbronn ( Site 2107)

    Heilbronn, Baden-Wurttemberg, 74078

  • Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 2101)

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum der Universität München Großhadern-Klinik und Poliklinik für Frauenheilkunde und Geburtshi ( Site 2109)

    Munich, Bavaria, 81337

  • MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum ( Site 2110)

    Ravensburg, Baden-Wurttemberg, 88212

  • Universitaetsklinikum Tuebingen ( Site 2111)

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Argentina7 sites

  • Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)

    Buenos Aires, Buenos Aires F.D., C1122AAL

  • Instituto Alexander Fleming-Alexander Fleming ( Site 1007)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

  • Hospital Aleman-Oncology ( Site 1001)

    Buenos Aires, C1118AAT

  • Instituto de Oncología Angel H. Roffo ( Site 1003)

    Buenos Aires, C1417DTB

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)

    Buenos Aires, C1431FWO

  • Hospital Británico de Buenos Aires-Oncology ( Site 1002)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)

    La Rioja, F5300COE

Other trials in Argentina

Czechia7 sites

  • Fakultní Nemocnice Brno-Gynekologicko-porodnicka klinika ( Site 1704)

    Brno, Brno-mesto, 602 00

  • Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706)

    Nový Jiín, Novy Jicin, 741 01

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702)

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703)

    Ostrava, Moravian-Silesian Region, 708 52

  • Fakultni nemocnice Kralovske Vinohrady ( Site 1707)

    Prague, Praha 10, 100 34

  • Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1705)

    Prague, Praha 2, 12808

  • Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701)

    Prague, Praha 8, 180 00

Other trials in Czechia

Israel6 sites

  • Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502)

    Haifa, 3109601

  • Edith Wolfson Medical Center ( Site 2501)

    Holon, 5810001

  • Shaare Zedek Medical Center ( Site 2503)

    Jerusalem, 9103102

  • Rabin Medical Center ( Site 2505)

    Petah Tikva, 4941492

  • Sheba Medical Center ( Site 2504)

    Ramat Gan, 5265601

  • Sourasky Medical Center ( Site 2506)

    Tel Aviv, 6423906

Other trials in Israel

Australia5 sites

  • Royal Brisbane and Women's Hospital ( Site 1102)

    Brisbane, Queensland, 4029

  • Epworth Freemasons ( Site 1104)

    East Melbourne, Victoria, 3002

  • Frankston Hospital ( Site 1105)

    Frankston, Victoria, 3199

  • GenesisCare North Shore ( Site 1103)

    St Leonards, New South Wales, 2065

  • Blacktown Hospital ( Site 1101)

    Sydney, New South Wales, 2148

Other trials in Australia

Belgium5 sites

  • AZ Maria Middelares-IKG ( Site 1305)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Gent-Medical oncology ( Site 1303)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven-Gynecologic Oncology ( Site 1301)

    Leuven, Vlaams-Brabant, 3000

  • CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304)

    Namur, 5000

  • AZ Delta vzw-Oncology ( Site 1302)

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Mexico5 sites

  • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2902)

    Coyoacán, Mexico City, 04700

  • Higiea Oncologia ( Site 2905)

    Mexico City, Mexico City, 11819

  • Centro de Investigacion Clinica de Oaxaca ( Site 2907)

    Oaxaca City, Oaxaca, 68020

  • Oncare - Unidad Valle ( Site 2906)

    San Pedro Garza García, Nuevo León, 66220

  • CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 2901)

    San Pedro Garza García, Nuevo León, 66278

Other trials in Mexico

South Korea5 sites

  • Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital ( Site 3502)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503)

    Seoul, 03722

  • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501)

    Seoul, 05505

  • Samsung Medical Center ( Site 3504)

    Seoul, 06351

Other trials in South Korea

Chile4 sites

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505)

    Santiago, Region M. de Santiago, 7500653

  • Pontificia Universidad Catolica de Chile ( Site 1503)

    Santiago, Region M. de Santiago, 8330024

  • Bradfordhill-Clinical Area ( Site 1501)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigacion del Cancer ( Site 1504)

    Temuco, Araucania, 4800827

Other trials in Chile

Finland4 sites

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902)

    Helsinki, Uusimaa, 00029

  • Kuopion Yliopistollinen Sairaala ( Site 1904)

    Kuopio, Northern Savonia, 70210

  • Tampereen yliopistollinen sairaala ( Site 1901)

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903)

    Turku, Southwest Finland, 20520

Other trials in Finland

Greece4 sites

  • Aretaieio Hospital Oncology Unit ( Site 2206)

    Athens, Attica, 115 28

  • Metropolitan Hospital-2nd Oncology Dept ( Site 2202)

    Athens, Attica, 185 47

  • Hygeia Hospital ( Site 2204)

    Marousi, Attica, 151 23

  • Agios Andreas Hospital Patras ( Site 2201)

    Pátrai, Achaia, 263 35

Other trials in Greece

Norway4 sites

  • Sorlandet Sykehus Kristiansand ( Site 3104)

    Kristiansand, Vest-Agder, 4615

  • Oslo universitetssykehus, Radiumhospitalet ( Site 3102)

    Oslo, 0379

  • Stavanger Universitetssykehus ( Site 3103)

    Stavanger, Rogaland, 4011

  • Universitetssykehuset Nord-Norge HF ( Site 3101)

    Tromsø, Troms, 9038

Other trials in Norway

Poland4 sites

  • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek ( Site 3202)

    Poznan, Greater Poland Voivodeship, 61-866

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201)

    Siedlce, Masovian Voivodeship, 08-110

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Site 3203)

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Switzerland4 sites

  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 3808)

    Basel, Canton of Basel-City, 4031

  • Ospedale Regionale Bellinzona e Valli ( Site 3802)

    Bellinzona, Canton Ticino, 6500

  • Inselspital Bern-Oncology ( Site 3801)

    Bern, 3010

  • Kantonsspital Graubünden-Medizin ( Site 3803)

    Chur, Kanton Graubünden, 7000

Other trials in Switzerland

Denmark3 sites

  • Aarhus Universitetshospital, Skejby ( Site 1802)

    Aarhus, Central Jutland, 8200

  • Herlev and Gentofte Hospital-Department of Oncology ( Site 1801)

    Copenhagen, Capital Region, 2730

  • Rigshospitalet-Dept. of Oncology ( Site 1803)

    Copenhagen, Capital Region, DK-2100

Other trials in Denmark

Ireland3 sites

  • Cork University Hospital ( Site 2402)

    Cork, T12 DC4A

  • Mater Misericordiae University Hospital ( Site 2403)

    Dublin, D07 R2WY

  • St. James's Hospital-Cancer clinical trials office ( Site 2401)

    Dublin, D08 E9P6

Other trials in Ireland

Netherlands3 sites

  • Amsterdam UMC - locatie VUmc ( Site 3004)

    Amsterdam, North Holland, 1081 HV

  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002)

    Leiden, South Holland, 2333 ZA

  • Radboudumc-Medical Oncology ( Site 3003)

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Puerto Rico3 sites

  • Ad-Vance Medical Research-Research ( Site 3302)

    Ponce, 00717

  • Pan American Center for Oncology Trials - Ciudadela ( Site 3301)

    San Juan, 00909

  • UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304)

    San Juan, 00935

Other trials in Puerto Rico

Austria2 sites

  • Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201)

    Innsbruck, Tyrol, 6020

  • Medizinische Universität Wien ( Site 1202)

    Vienna, 1090

Other trials in Austria

Malaysia2 sites

  • Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803)

    Kuala Lumpur, 59100

  • University Malaya Medical Centre ( Site 2801)

    Kuala Lumpur, 59100

Other trials in Malaysia

Sweden2 sites

  • Skånes Universitetssjukhus Lund ( Site 3702)

    Lund, Skåne County, 22185

  • Karolinska Universitetssjukhuset Solna ( Site 3701)

    Stockholm, Stockholm County, 171 76

Other trials in Sweden

Singapore1 site

  • National Cancer Centre Singapore-Medical Oncology ( Site 3401)

    Singapore, Central Singapore, 168583

Other trials in Singapore

About this study

Official title: 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.

Being tested
Sacituzumab tirumotecan, Doxorubicin, Paclitaxel, Nab-paclitaxel, Rescue medications
Keywords
Endometrial cancer, Antibody-drug conjugate (ADC), Trophoblast cell-surface antigen 2 (TROP2)
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • Sacituzumab tirumotecanBiological

    Also called SKB264 MK-2870

    4 mg/kg of sacituzumab tirumotecan by IV infusion

  • DoxorubicinDrug

    Also called ADRIAMYCIN®

    60 mg/m^2 of doxorubicin by IV Infusion

  • PaclitaxelDrug

    Also called TAXOL®

    80 mg/m^2 of paclitaxel by IV infusion

  • Nab-paclitaxelDrug

    Also called Abraxane

    100 mg/m^2 of nab-paclitaxel by IV infusion

  • Rescue medicationsDrug

    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).

Study groups in NCT06132958
Study groupRoleWhat they receive
Sacituzumab tirumotecanExperimentalParticipants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medications
ChemotherapyActive comparatorParticipants 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.
Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: Nab-paclitaxel

What is being measured

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

  1. 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.

    Measured: Up to approximately 27 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 48 months

Secondary outcomes (5)

  1. 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.

    Measured: Up to approximately 27 months

  2. 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.

    Measured: Up to approximately 27 months

  3. 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.

    Measured: Up to approximately 48 months

  4. 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.

    Measured: Up to approximately 48 months

  5. 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.

    Measured: Baseline, up to approximately 48 months

Timeline

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

  1. First posted15 Nov 2023
  2. Study start6 Dec 2023
  3. Primary completion10 Jan 2028 (estimated)
  4. Study completion10 Jan 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
710 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06132958
Sponsor's protocol ID
2870-005
Other IDs
2023-504816-14-00, U1111-1288-7581, jRCT2031240041, 2023
Acronym
TroFuse-005
Status last verified
Aug 2026
First submitted
10 Nov 2023
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Lorusso D, Martin-Babau J, Backes F, Ginesta MPB, Korach J, Nicum S, Wampfler J, Zhu J, Ducceschi M, Van Gorp T, Frodin-Bolling M, Zagouri F, Kroep JR, Ray-Coquard I, Salutari V, Lightfoot MDS, Tillmanns T, O'Malley DM, Hasegawa K, Lee JY, Giornelli GH, Samouelian V, Antill Y, Li J, Nishio S, Chan JJ, Monk BJ, Li C, Woodhouse K, Orlowski R, Garcia-Duran C, Pothuri B; TroFuse-005/ENGOT-en23/GOG-3095 Investigators. Sacituzumab tirumotecan versus treatment of physician's choice in previously treated endometrial cancer (TroFuse-005/ENGOT-en23/GOG-3095): a randomised, open-label, phase 3 trial. Lancet. 2026 Oct 26:S0140-6736(26)02099-4. doi: 10.1016/S0140-6736(26)02099-4. Online ahead of print.

    PubMed 42933460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC at 242 sites in 31 countries.

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 242 sites in United States, China, Japan, Italy, France and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06132958, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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