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A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
Sponsor: Merck Sharp & Dohme LLC
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).
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2024-05-03
Completion Date
2027-05-06
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Sacituzumab tirumotecan
Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15, and 29 of every 42-day cycle.
Trifluridine-Tipiracil
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.
Irinotecan
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.
Paclitaxel
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.
Docetaxel
Docetaxel will be administered at a dose of 75 mg/m\^2 by IV infusion on day 1 of a 21-day cycle.
Rescue medications
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 measures
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.
Locations (168)
Banner MD Anderson Cancer Center ( Site 0119)
Gilbert, Arizona, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0140)
Los Angeles, California, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)
Orlando, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)
Marietta, Georgia, United States
University of Chicago Medical Center ( Site 0120)
Chicago, Illinois, United States
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)
Lexington, Kentucky, United States
The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113)
Louisville, Kentucky, United States
Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)
Louisville, Kentucky, United States
Henry Ford Hospital ( Site 0107)
Detroit, Michigan, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138)
Fargo, North Dakota, United States
Oregon Health and Science University ( Site 0104)
Portland, Oregon, United States
UPMC Hillman Cancer Center ( Site 0126)
Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122)
Charleston, South Carolina, United States
Sanford Cancer Center ( Site 0136)
Sioux Falls, South Dakota, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0110)
Germantown, Tennessee, United States
Inova Schar Cancer ( Site 0106)
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center ( Site 0111)
Seattle, Washington, United States
Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven-Digestive Oncology ( Site 1000)
Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw ( Site 1002)
Roeselare, West-Vlaanderen, Belgium
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405)
Fortaleza, Ceará, Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406)
Natal, Rio Grande do Norte, Brazil
Hospital de Caridade de Ijuí ( Site 0412)
Ijuí, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0400)
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e Oncologia ( Site 0404)
Joinville, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0401)
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0411)
São José do Rio Preto, São Paulo, Brazil
A. C. Camargo Cancer Center ( Site 0409)
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0402)
São Paulo, Brazil
McGill University Health Centre ( Site 0201)
Montreal, Quebec, Canada
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503)
Santiago, Region M. de Santiago, Chile
FALP-UIDO ( Site 0500)
Santiago, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0501)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigacion del Cancer ( Site 0506)
Temuco, Región de la Araucanía, Chile
Anhui Provincial Cancer Hospital-medical oncology ( Site 3016)
Hefei, Anhui, China
Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038)
Hefei, Anhui, China
Chongqing University Three Gorges Hospital ( Site 3036)
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital ( Site 3007)
Fuzhou, Fujian, China
The 900th Hospital of the Joint Logistics Support Force of PLA ( Site 3008)
Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University-oncology ( Site 3011)
Xiamen, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 3013)
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 3001)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019)
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College ( Site 3034)
Shantou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047)
Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University ( Site 3015)
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3005)
Harbin, Heilongjiang, China
Henan Cancer Hospital-henan cancer hospital ( Site 3002)
Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 3012)
Wuhan, Hubei, China
Xiangyang Central Hospital ( Site 3045)
Xiangyang, Hubei, China
Hunan Cancer Hospital ( Site 3014)
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University ( Site 3040)
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3037)
Nanchang, Jiangxi, China
Jilin Province Tumor Hospital ( Site 3018)
Changchun, Jilin, China
LinYi Cancer Hospital-Gastrology department ( Site 3024)
Linyi, Shandong, China
Fudan University Shanghai Cancer Center-medical oncology ( Site 3009)
Shanghai, Shanghai Municipality, China
Zhongshan Hospital,Fudan University-Oncology ( Site 3003)
Shanghai, Shanghai Municipality, China
Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3042)
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 3035)
Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 3030)
Chengdu, Sichuan, China
Beijing Anzhen Nanchong Hospital of Capital Medical University (Nanchong Central Hospital) ( Site 3029)
Nanchong, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumchi-The No.11 of Surgery building ( Site 3010)
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital ( Site 3031)
Kunming, Yunnan, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital-Oncology ( Site 3021)
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 3020)
Linhai, Zhejiang, China
Yueqing People's Hospital ( Site 3041)
Yueqing, Zhejiang, China
Centro Cancerológico del Caribe (CECAC) ( Site 0606)
Barranquilla, Atlántico, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0602)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0600)
Valledupar, Cesar Department, Colombia
Fundación Valle del Lili-Fundacion Valle del Lili ( Site 0607)
Cali, Valle del Cauca Department, Colombia
Rigshospitalet ( Site 1102)
Copenhagen, Capital Region, Denmark
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103)
Aalborg, North Denmark, Denmark
Odense Universitetshospital-Department of oncology ( Site 1101)
Odense, Region Syddanmark, Denmark
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211)
Bordeaux, Aquitaine, France
CENTRE LEON BERARD-Medical oncology ( Site 1208)
Lyon, Auvergne-Rhône-Alpes, France
Centre François Baclesse ( Site 1202)
Caen, Calvados, France
CHU Rangueil-Digestive oncology department ( Site 1210)
Toulouse, Haute-Garonne, France
Centre Oscar Lambret ( Site 1206)
Lille, Hauts-de-France, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203)
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire de Poitiers ( Site 1209)
Poitiers, Vienne, France
Hôpital Saint-Louis ( Site 1201)
Paris, France
Institut Mutualiste Montsouris-Oncology ( Site 1216)
Paris, Île-de-France Region, France
NCT-Department of Medical Oncology ( Site 1302)
Heidelberg, Baden-Wurttemberg, Germany
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1310)
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 1307)
Dresden, Saxony, Germany
Städtisches Krankenhaus Kiel-2. Medizinische Klinik ( Site 1306)
Kiel, Schleswig-Holstein, Germany
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 1304)
Berlin, Germany
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300)
Hamburg, Germany
Queen Mary Hospital ( Site 3100)
Hong Kong, Hong Kong
Prince of Wales Hospital ( Site 3102)
Shatin, Hong Kong
Queen Elizabeth Hospital ( Site 3101)
Yau Ma Tei, Hong Kong
Hillel Yaffe Medical Center ( Site 1604)
Hadera, Israel
Rambam Health Care Campus-Oncology Division ( Site 1600)
Haifa, Israel
Hadassah Medical Center ( Site 1603)
Jerusalem, Israel
Rabin Medical Center ( Site 1605)
Petah Tikva, Israel
Sourasky Medical Center ( Site 1602)
Tel Aviv, Israel
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1704)
Naples, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700)
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana ( Site 1702)
Pisa, Tuscany, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1701)
Milan, Italy
Aichi Cancer Center ( Site 3307)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 3300)
Kashiwa, Chiba, Japan
Kochi Medical School Hospital ( Site 3304)
Nankoku, Kochi, Japan
Saitama Prefectural Cancer Center ( Site 3302)
Kitaadachi-gun, Saitama, Japan
National Cancer Center Hospital ( Site 3301)
Chūō, Tokyo, Japan
Cancer Institute Hospital of JFCR ( Site 3306)
Koto, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3303)
Fukuoka, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3305)
Osaka, Japan
Hospital Pulau Pinang ( Site 3403)
George Town, Pulau Pinang, Malaysia
National Cancer Institute-Radiotherapy and Oncology ( Site 3404)
Putrajaya, Putrajaya, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 3401)
Kuching, Sarawak, Malaysia
University Malaya Medical Centre-Clinical Oncology ( Site 3402)
Kuala Lumpur, Malaysia
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408)
Kuala Lumpur, Malaysia
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0814)
Guadalajara, Jalisco, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 0802)
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 0805)
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0809)
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0810)
Oaxaca City, Oaxaca, Mexico
Centro Potosino de Investigación Médica ( Site 0801)
San Luis Potosí City, San Luis Potosí, Mexico
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904)
Concepción, Departamento de Junín, Peru
Hospital de Alta Complejidad La Libertad-Unidad de Investigación en Oncología ( Site 0902)
Trujillo, La Libertad, Peru
Clínicas AUNA Sede Chiclayo ( Site 0907)
Chiclayo, Lambayeque, Peru
Clínica Internacional - Sede San Borja ( Site 0906)
Lima, Peru
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905)
Lima, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0900)
Lima, Peru
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1800)
Warsaw, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 1804)
Bialystok, Podlaskie Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej " Profil Jednego Dnia " ( Site 1810)
Gdynia, Pomeranian Voivodeship, Poland
Szpital Wojewódzki w Koszalinie. ( Site 1801)
Poland, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811)
Kielce, Świętokrzyskie Voivodeship, Poland
Seoul National University Bundang Hospital ( Site 3504)
Seongnam, Kyonggi-do, South Korea
Seoul National University Hospital-Oncology ( Site 3503)
Seoul, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500)
Seoul, South Korea
Asan Medical Center-Department of Oncology ( Site 3501)
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3502)
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505)
Seoul, South Korea
Hospital Universitario Marqués de Valdecilla ( Site 1901)
Santander, Cantabria, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905)
A Coruña, La Coruna, Spain
COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904)
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900)
Barcelona, Spain
Hospital Clinico San Carlos ( Site 1903)
Madrid, Spain
China Medical University Hospital ( Site 3603)
Taichung, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604)
Tainan, Taiwan
National Taiwan University Hospital ( Site 3600)
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 3601)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3602)
Taoyuan District, Taiwan
Chulalongkorn University ( Site 3702)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 3700)
Bangkok, Bangkok, Thailand
Songklanagarind hospital ( Site 3701)
Hat Yai, Changwat Songkhla, Thailand
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2104)
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)
Ankara, Turkey (Türkiye)
Dicle Üniversitesi-oncology ( Site 2108)
Diyarbakır, Turkey (Türkiye)
Atatürk Üniversitesi-onkoloji ( Site 2111)
Erzurum, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2106)
Istanbul, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 2110)
Samsun, Turkey (Türkiye)
Yuzuncu Yil University Dursun Odaba Tp Merkezi-Medical Oncology ( Site 2109)
Van, Turkey (Türkiye)
Addenbrooke's Hospital ( Site 2203)
Cambridge, Cambridgeshire, United Kingdom
Ninewells Hospital and Medical School-Oncology Petty ( Site 2209)
Dundee, Dundee City, United Kingdom
St Bartholomew's Hospital ( Site 2206)
London, London, City of, United Kingdom
The Christie NHS Foundation Trust-Medical Oncology ( Site 2201)
Manchester, United Kingdom