AzTrials
AzTrials

Gastroesophageal CancerPhase 3TroFuse-015NCT06356311

A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

A Phase 3 study testing Sacituzumab tirumotecan, Trifluridine-Tipiracil and Irinotecan in people with Gastroesophageal Cancer, run by Merck Sharp & Dohme LLC at 168 sites in 24 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

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Cancer
What is being tested?
Sacituzumab tirumotecan, Trifluridine-Tipiracil and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
473 participants
Where
168 sitesin 24 countries
Study dates
3 May 2024to 6 May 2027
Phase
Phase 3

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a histologically or cytologically confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
  • Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens for advanced, unresectable or metastatic gastroesophageal adenocarcinoma
  • Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab where available/appropriate
  • Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification
  • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible
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  • Has adequate organ function
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization
  • Has ability to swallow oral medication for those who may receive trifluridine-tipiracil
  • Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
  • Hepatitis B surface antigen (HBsAg)-positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot join

  • 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 Grade ≥2 peripheral neuropathy
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention
  • Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention
  • Has received prior treatment with TROP2-targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor-based ADC, and/or a topoisomerase 1 inhibitor-based chemotherapy
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  • Has received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention
  • Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently receiving a strong and/or moderate inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks
  • Has received an investigational agent or has used an investigational device within 4 weeks before 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 known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castlemans's Disease
  • Has concurrent active hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid [DNA]) and HCV (defined as anti-HCV antibody [Ab] positive and detectable HCV ribonucleic acid [RNA]) infection
  • Has severe hypersensitivity (Grades >=3) to the study interventions, any of their excipients, and/or to another biologic therapy
  • Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary
  • Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Trial locations and contacts

168 sites in 24 countries.

168 sites in 24 countries

China33 sites

  • Jilin Province Tumor Hospital ( Site 3018)

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital ( Site 3014)

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University ( Site 3035)

    Chengdu, Sichuan, 610041

  • Sichuan Cancer hospital. ( Site 3030)

    Chengdu, Sichuan, 610213

  • Chongqing University Three Gorges Hospital ( Site 3036)

    Chongqing, Chongqing Municipality, 404000

  • Fujian Cancer Hospital ( Site 3007)

    Fuzhou, Fujian, 350014

  • The 900th Hospital of the Joint Logistics Support Force of PLA ( Site 3008)

    Fuzhou, Fujian, 350025

  • Sun Yat-Sen University Cancer Center ( Site 3001)

    Guangzhou, Guangdong, 510060

  • Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019)

    Guangzhou, Guangdong, 510515

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006)

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital-Oncology ( Site 3021)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3005)

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Cancer Hospital-medical oncology ( Site 3016)

    Hefei, Anhui, 230000

  • Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038)

    Hefei, Anhui, 230000

  • Yunnan Province Cancer Hospital ( Site 3031)

    Kunming, Yunnan, 650107

  • Taizhou Hospital of Zhejiang Province ( Site 3020)

    Linhai, Zhejiang, 317000

  • LinYi Cancer Hospital-Gastrology department ( Site 3024)

    Linyi, Shandong, 276000

  • The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3037)

    Nanchang, Jiangxi, 330006

  • Beijing Anzhen Nanchong Hospital of Capital Medical University (Nanchong Central Hospital) ( Site 3029)

    Nanchong, Sichuan, 637199

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047)

    Nanning, Guangxi, 530201

  • Fudan University Shanghai Cancer Center-medical oncology ( Site 3009)

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital,Fudan University-Oncology ( Site 3003)

    Shanghai, Shanghai Municipality, 200032

  • Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3042)

    Shanghai, Shanghai Municipality, 200127

  • Cancer Hospital of Shantou University Medical College ( Site 3034)

    Shantou, Guangdong, 515041

  • Fourth Hospital of Hebei Medical University ( Site 3015)

    Shijiazhuang, Hebei, 050035

  • The First Affiliated Hospital of Soochow University ( Site 3040)

    Suzhou, Jiangsu, 215006

  • Xinjiang Medical University Cancer Hospital - Urumchi-The No.11 of Surgery building ( Site 3010)

    Ürümqi, Xinjiang, 830011

  • Hubei Cancer Hospital ( Site 3012)

    Wuhan, Hubei, 430079

  • The First Affiliated hospital of Xiamen University-oncology ( Site 3011)

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 3013)

    Xiamen, Fujian, 361004

  • Xiangyang Central Hospital ( Site 3045)

    Xiangyang, Hubei, 441106

  • Yueqing People's Hospital ( Site 3041)

    Yueqing, Zhejiang, 325699

  • Henan Cancer Hospital-henan cancer hospital ( Site 3002)

    Zhengzhou, Henan, 450000

Other trials in China

United States17 sites

  • MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122)

    Charleston, South Carolina, 29425

  • University of Chicago Medical Center ( Site 0120)

    Chicago, Illinois, 60637

  • Henry Ford Hospital ( Site 0107)

    Detroit, Michigan, 48202

  • Inova Schar Cancer ( Site 0106)

    Fairfax, Virginia, 22031

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138)

    Fargo, North Dakota, 58122

  • The West Clinic, PLLC dba West Cancer Center ( Site 0110)

    Germantown, Tennessee, 38138

  • Banner MD Anderson Cancer Center ( Site 0119)

    Gilbert, Arizona, 85234

  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)

    Lexington, Kentucky, 40536

  • UCLA Hematology/Oncology - Santa Monica ( Site 0140)

    Los Angeles, California, 90404

  • The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113)

    Louisville, Kentucky, 40202

  • Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)

    Louisville, Kentucky, 40217

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)

    Marietta, Georgia, 30060

  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)

    Orlando, Florida, 32804

  • UPMC Hillman Cancer Center ( Site 0126)

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University ( Site 0104)

    Portland, Oregon, 97239

  • Fred Hutchinson Cancer Center ( Site 0111)

    Seattle, Washington, 98109

  • Sanford Cancer Center ( Site 0136)

    Sioux Falls, South Dakota, 57104

Other trials in United States

Brazil9 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0401)

    Barretos, São Paulo, 14784-400

  • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405)

    Fortaleza, Ceará, 60430235

  • Hospital de Caridade de Ijuí ( Site 0412)

    Ijuí, Rio Grande do Sul, 98700 000

  • Centro de Hematologia e Oncologia ( Site 0404)

    Joinville, Santa Catarina, 89202-050

  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406)

    Natal, Rio Grande do Norte, 59075-740

  • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0400)

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0411)

    São José do Rio Preto, São Paulo, 15090000

  • A. C. Camargo Cancer Center ( Site 0409)

    São Paulo, 01509-010

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0402)

    São Paulo, 04014-012

Other trials in Brazil

France9 sites

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211)

    Bordeaux, Aquitaine, 33076

  • Centre François Baclesse ( Site 1202)

    Caen, Calvados, 14076

  • Centre Oscar Lambret ( Site 1206)

    Lille, Hauts-de-France, 59020

  • CENTRE LEON BERARD-Medical oncology ( Site 1208)

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Hôpital Saint-Louis ( Site 1201)

    Paris, 75475

  • Institut Mutualiste Montsouris-Oncology ( Site 1216)

    Paris, Île-de-France Region, 75014

  • Centre Hospitalier Universitaire de Poitiers ( Site 1209)

    Poitiers, Vienne, 86021

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203)

    Rennes, Ille-et-Vilaine, 35042

  • CHU Rangueil-Digestive oncology department ( Site 1210)

    Toulouse, Haute-Garonne, 31059

Other trials in France

Japan8 sites

  • National Cancer Center Hospital ( Site 3301)

    Chūō, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center ( Site 3303)

    Fukuoka, 811-1395

  • National Cancer Center Hospital East ( Site 3300)

    Kashiwa, Chiba, 277-8577

  • Saitama Prefectural Cancer Center ( Site 3302)

    Kitaadachi-gun, Saitama, 362-0806

  • Cancer Institute Hospital of JFCR ( Site 3306)

    Koto, Tokyo, 135-8550

  • Aichi Cancer Center ( Site 3307)

    Nagoya, Aichi-ken, 464-8681

  • Kochi Medical School Hospital ( Site 3304)

    Nankoku, Kochi, 783-8505

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3305)

    Osaka, 541-8567

Other trials in Japan

Turkey (Türkiye)8 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2104)

    Adana, 01250

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)

    Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)

    Ankara, 06800

  • Dicle Üniversitesi-oncology ( Site 2108)

    Diyarbakır, 21100

  • Atatürk Üniversitesi-onkoloji ( Site 2111)

    Erzurum, 25070

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2106)

    Istanbul, 34722

  • Samsun Medical Park Hastanesi-medical oncology ( Site 2110)

    Samsun, 55200

  • Yuzuncu Yil University Dursun Odaba Tp Merkezi-Medical Oncology ( Site 2109)

    Van, 65200

Other trials in Turkey (Türkiye)

Germany6 sites

  • Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 1304)

    Berlin, 13353

  • Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 1307)

    Dresden, Saxony, 01307

  • Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1310)

    Göttingen, Lower Saxony, 37075

  • Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300)

    Hamburg, 20249

  • NCT-Department of Medical Oncology ( Site 1302)

    Heidelberg, Baden-Wurttemberg, 69120

  • Städtisches Krankenhaus Kiel-2. Medizinische Klinik ( Site 1306)

    Kiel, Schleswig-Holstein, 24116

Other trials in Germany

Mexico6 sites

  • CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0814)

    Guadalajara, Jalisco, 44260

  • COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 0802)

    Mexico City, Mexico City, 04700

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 0805)

    Mexico City, Mexico City, 14080

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0809)

    Monterrey, Nuevo León, 64460

  • Centro de Investigacion Clinica de Oaxaca ( Site 0810)

    Oaxaca City, Oaxaca, 68020

  • Centro Potosino de Investigación Médica ( Site 0801)

    San Luis Potosí City, San Luis Potosí, 78250

Other trials in Mexico

Peru6 sites

  • Clínicas AUNA Sede Chiclayo ( Site 0907)

    Chiclayo, Lambayeque, 14001

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904)

    Concepción, Departamento de Junín, 12125

  • Clínica Internacional - Sede San Borja ( Site 0906)

    Lima, 15036

  • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905)

    Lima, 15036

  • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0900)

    Lima, 15038

  • Hospital de Alta Complejidad La Libertad-Unidad de Investigación en Oncología ( Site 0902)

    Trujillo, La Libertad, 13002

Other trials in Peru

Poland6 sites

  • Bialostockie Centrum Onkologii ( Site 1804)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej " Profil Jednego Dnia " ( Site 1810)

    Gdynia, Pomeranian Voivodeship, 81-519

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811)

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • Szpital Wojewódzki w Koszalinie. ( Site 1801)

    Poland, West Pomeranian Voivodeship, 75-581

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1800)

    Warsaw, Masovian Voivodeship, 02-034

Other trials in Poland

South Korea6 sites

  • Seoul National University Bundang Hospital ( Site 3504)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital-Oncology ( Site 3503)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500)

    Seoul, 03722

  • Asan Medical Center-Department of Oncology ( Site 3501)

    Seoul, 05505

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 3502)

    Seoul, 06351

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505)

    Seoul, 06591

Other trials in South Korea

Spain6 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905)

    A Coruña, La Coruna, 15006

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900)

    Barcelona, 08035

  • Hospital Clinico San Carlos ( Site 1903)

    Madrid, 28040

  • Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902)

    Oviedo, Principality of Asturias, 33011

  • COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904)

    Pamplona, Navarre, 31009

  • Hospital Universitario Marqués de Valdecilla ( Site 1901)

    Santander, Cantabria, 39008

Other trials in Spain

Chile5 sites

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503)

    Santiago, Region M. de Santiago, 7500653

  • FALP-UIDO ( Site 0500)

    Santiago, Region M. de Santiago, 7500921

  • Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502)

    Santiago, Region M. de Santiago, 7620002

  • Bradfordhill-Clinical Area ( Site 0501)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigacion del Cancer ( Site 0506)

    Temuco, Araucania, 4800827

Other trials in Chile

Colombia5 sites

  • Centro Cancerológico del Caribe (CECAC) ( Site 0606)

    Barranquilla, Atlántico, 080001

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0602)

    Bogotá, Bogota D.C., 110131

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)

    Bogotá, Bogota D.C., 111321

  • Fundación Valle del Lili-Fundacion Valle del Lili ( Site 0607)

    Cali, Valle del Cauca Department, 760032

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0600)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Israel5 sites

  • Hillel Yaffe Medical Center ( Site 1604)

    Hadera, 3810101

  • Rambam Health Care Campus-Oncology Division ( Site 1600)

    Haifa, 3109601

  • Hadassah Medical Center ( Site 1603)

    Jerusalem, 9112001

  • Rabin Medical Center ( Site 1605)

    Petah Tikva, 4941492

  • Sourasky Medical Center ( Site 1602)

    Tel Aviv, 64239

Other trials in Israel

Italy5 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700)

    Milan, Lombardy, 20133

  • Ospedale San Raffaele-Oncologia Medica ( Site 1701)

    Milan, 20132

  • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1704)

    Naples, Campania, 80131

  • Azienda Ospedaliero Universitaria Pisana ( Site 1702)

    Pisa, Tuscany, 56126

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703)

    Rome, Lazio, 00168

Other trials in Italy

Malaysia5 sites

  • Hospital Pulau Pinang ( Site 3403)

    George Town, Pulau Pinang, 10450

  • University Malaya Medical Centre-Clinical Oncology ( Site 3402)

    Kuala Lumpur, 50603

  • Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408)

    Kuala Lumpur, 59100

  • Sarawak General Hospital-Radiotherapy Unit ( Site 3401)

    Kuching, Sarawak, 93586

  • National Cancer Institute-Radiotherapy and Oncology ( Site 3404)

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Taiwan5 sites

  • China Medical University Hospital ( Site 3603)

    Taichung, 404332

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604)

    Tainan, 704

  • National Taiwan University Hospital ( Site 3600)

    Taipei, 10002

  • Taipei Veterans General Hospital ( Site 3601)

    Taipei, 112

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3602)

    Taoyuan, 33305

Other trials in Taiwan

Belgium4 sites

  • Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003)

    Anderlecht, Bruxelles-Capitale, Region de, 1070

  • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • UZ Leuven-Digestive Oncology ( Site 1000)

    Leuven, Vlaams-Brabant, 3000

  • AZ Delta vzw ( Site 1002)

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

United Kingdom4 sites

  • Addenbrooke's Hospital ( Site 2203)

    Cambridge, Cambridgeshire, CB2 2QQ

  • Ninewells Hospital and Medical School-Oncology Petty ( Site 2209)

    Dundee, Dundee City, DD2 1SG

  • St Bartholomew's Hospital ( Site 2206)

    London, London, City of, EC1A 7BE

  • The Christie NHS Foundation Trust-Medical Oncology ( Site 2201)

    Manchester, m20 4bx

Other trials in United Kingdom

Denmark3 sites

  • Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103)

    Aalborg, North Denmark, 9000

  • Rigshospitalet ( Site 1102)

    Copenhagen, Capital Region, 2100

  • Odense Universitetshospital-Department of oncology ( Site 1101)

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Hong Kong3 sites

  • Queen Mary Hospital ( Site 3100)

    Hong Kong

  • Prince of Wales Hospital ( Site 3102)

    Shatin

  • Queen Elizabeth Hospital ( Site 3101)

    Yau Ma Tei, 999077

Other trials in Hong Kong

Thailand3 sites

  • Chulalongkorn University ( Site 3702)

    Bangkok, Bangkok, 10330

  • Faculty of Medicine Siriraj Hospital ( Site 3700)

    Bangkok, Bangkok, 10700

  • Songklanagarind hospital ( Site 3701)

    Hat Yai, Changwat Songkhla, 90110

Other trials in Thailand

Canada1 site

  • McGill University Health Centre ( Site 0201)

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician's Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

Being tested
Sacituzumab tirumotecan, Trifluridine-Tipiracil, Irinotecan, Paclitaxel, Docetaxel
Keywords
Gastroesophageal cancer, Gastroesophageal adenocarcinoma, Gastric adenocarcinoma, Esophageal adenocarcinoma
Medical subject headings
Adenocarcinoma Of Esophagus

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

    Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15, and 29 of every 42-day cycle.

  • Trifluridine-TipiracilDrug

    Trifluridine-tipiracil will be administered at 35 mg/m^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle.

  • IrinotecanDrug

    Irinotecan will be administered at a dose of 150 mg/m^2 by IV infusion on days 1 and 15 of every 28-day cycle.

  • PaclitaxelDrug

    Paclitaxel will be administered at a dose of 80 mg/m^2 by IV infusion on days 1, 8 and 15 of every 28-day cycle.

  • DocetaxelDrug

    Docetaxel will be administered at a dose of 75 mg/m^2 by IV infusion on day 1 of a 21-day cycle.

  • Rescue medicationsDrug

    Participants are required to receive prophylactic mouthwash (steroid mouthwash [dexamethasone or equivalent] is highly recommended) to mitigate the onset and severity of stomatitis or oral mucositis. Additionally, participants may receive mucoadhesive hydrogel and oral nystatin suspension or other topical antifungal agents. Additional recommended rescue medications are histamine-1 (H1) receptor antagonist, H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, at the investigator's discretion.

  • Supportive care measuresDrug

    Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Study groups in NCT06356311
Study groupRoleWhat they receive
Sacituzumab tirumotecanExperimentalParticipants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medications; Drug: Supportive care measures
Treatment of Physician's Choice (TPC)Active comparatorTPC include either trifluridine-tipiracil (35 mg/m^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m^2 IV on day 1 of every 21-day cycle).
Receives: Drug: Trifluridine-Tipiracil; Drug: Irinotecan; Drug: Paclitaxel; Drug: Docetaxel; Drug: Supportive care measures

What is being measured

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

  1. Overall Survival (OS)

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

    Measured: Up to ~ 31 months

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    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 blinded independent central review (BICR) will be presented.

    Measured: Up to ~ 25 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or 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 BICR will be presented.

    Measured: Up to ~ 25 months

  3. Duration of Response (DOR)

    For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. 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 BICR will be presented.

    Measured: Up to ~ 25 months

  4. Number of Participants Who Experience an Adverse Event (AE)

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to ~ 36 months

  5. Number of Participants Who Discontinue Study Intervention Due to an AE

    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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to ~ 36 months

Timeline

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

  1. First posted10 Apr 2024
  2. Study start3 May 2024
  3. Primary completion19 Oct 2026
  4. Study completion6 May 2027 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356311
Sponsor's protocol ID
2870-015
Other IDs
2023-505423-31-00, U1111-1291-7109, MK-2870-015, jRCT2031240133, 2023
Acronym
TroFuse-015
Status last verified
Oct 2026
First submitted
4 Apr 2024
Last updated
22 Oct 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

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