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

NCT06356311 | Active Not Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 2870-0152023-505423-31-00U1111-1291-7109MK-2870-015jRCT2031240133
• Study Type: interventional
• Target: 450
• Locations: 24 countries
• Sites: 168

Brief 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).

Conditions

Gastroesophageal Cancer

Keywords

Gastroesophageal cancer; Gastroesophageal adenocarcinoma; Gastric adenocarcinoma; Esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

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

  Up to ~ 31 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to ~ 25 months

• Objective Response Rate (ORR)

  Up to ~ 25 months

• Duration of Response (DOR)

  Up to ~ 25 months

• Number of Participants Who Experience an Adverse Event (AE)

  Up to ~ 36 months

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to ~ 36 months

Study Arms (2)

Sacituzumab tirumotecan

EXPERIMENTAL

Participants 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.

Biological: Sacituzumab tirumotecan; Drug: Rescue medications; Drug: Supportive care measures

Treatment of Physician's Choice (TPC)

ACTIVE COMPARATOR

TPC 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).

Drug: Trifluridine-Tipiracil; Drug: Irinotecan; Drug: Paclitaxel; Drug: Docetaxel; Drug: Supportive care measures

Interventions

Rescue medications DRUG

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.

Sacituzumab tirumotecan

Sacituzumab tirumotecan BIOLOGICAL

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

Also known as: SKB264, MK-2870

Sacituzumab tirumotecan

Trifluridine-Tipiracil DRUG

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.

Treatment of Physician's Choice (TPC)

Irinotecan DRUG

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.

Treatment of Physician's Choice (TPC)

Paclitaxel DRUG

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.

Treatment of Physician's Choice (TPC)

Docetaxel DRUG

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

Treatment of Physician's Choice (TPC)

Supportive care measures DRUG

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.

Sacituzumab tirumotecan; Treatment of Physician's Choice (TPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (168)

Banner MD Anderson Cancer Center ( Site 0119)

Gilbert, Arizona, 85234, United States

Location

UCLA Hematology/Oncology - Santa Monica ( Site 0140)

Los Angeles, California, 90404, United States

Location

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

Orlando, Florida, 32804, United States

Location

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

Marietta, Georgia, 30060, United States

Location

University of Chicago Medical Center ( Site 0120)

Chicago, Illinois, 60637, United States

Location

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

Lexington, Kentucky, 40536, United States

Location

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

Louisville, Kentucky, 40202, United States

Location

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

Louisville, Kentucky, 40217, United States

Location

Henry Ford Hospital ( Site 0107)

Detroit, Michigan, 48202, United States

Location

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

Fargo, North Dakota, 58122, United States

Location

Oregon Health and Science University ( Site 0104)

Portland, Oregon, 97239, United States

Location

UPMC Hillman Cancer Center ( Site 0126)

Pittsburgh, Pennsylvania, 15232, United States

Location

MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122)

Charleston, South Carolina, 29425, United States

Location

Sanford Cancer Center ( Site 0136)

Sioux Falls, South Dakota, 57104, United States

Location

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

Germantown, Tennessee, 38138, United States

Location

Inova Schar Cancer ( Site 0106)

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Center ( Site 0111)

Seattle, Washington, 98109, United States

Location

Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003)

Anderlecht, Bruxelles-Capitale, Region de, 1070, Belgium

Location

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

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

UZ Leuven-Digestive Oncology ( Site 1000)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta vzw ( Site 1002)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

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

Fortaleza, Ceará, 60430235, Brazil

Location

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

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital de Caridade de Ijuí ( Site 0412)

Ijuí, Rio Grande do Sul, 98700 000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Centro de Hematologia e Oncologia ( Site 0404)

Joinville, Santa Catarina, 89202-050, Brazil

Location

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

Barretos, São Paulo, 14784-400, Brazil

Location

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

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

A. C. Camargo Cancer Center ( Site 0409)

São Paulo, 01509-010, Brazil

Location

IBCC - Núcleo de Pesquisa e Ensino ( Site 0402)

São Paulo, 04014-012, Brazil

Location

McGill University Health Centre ( Site 0201)

Montreal, Quebec, H4A 3J1, Canada

Location

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503)

Santiago, Region M. de Santiago, 7500653, Chile

Location

FALP-UIDO ( Site 0500)

Santiago, Region M. de Santiago, 7500921, Chile

Location

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

Santiago, Region M. de Santiago, 7620002, Chile

Location

Bradfordhill-Clinical Area ( Site 0501)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigacion del Cancer ( Site 0506)

Temuco, Región de la Araucanía, 4800827, Chile

Location

Anhui Provincial Cancer Hospital-medical oncology ( Site 3016)

Hefei, Anhui, 230000, China

Location

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

Hefei, Anhui, 230000, China

Location

Chongqing University Three Gorges Hospital ( Site 3036)

Chongqing, Chongqing Municipality, 404000, China

Location

Fujian Cancer Hospital ( Site 3007)

Fuzhou, Fujian, 350014, China

Location

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

Fuzhou, Fujian, 350025, China

Location

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

Xiamen, Fujian, 361003, China

Location

Zhongshan Hospital Affiliated to Xiamen University ( Site 3013)

Xiamen, Fujian, 361004, China

Location

Sun Yat-Sen University Cancer Center ( Site 3001)

Guangzhou, Guangdong, 510060, China

Location

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

Guangzhou, Guangdong, 510515, China

Location

Cancer Hospital of Shantou University Medical College ( Site 3034)

Shantou, Guangdong, 515041, China

Location

Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047)

Nanning, Guangxi, 530201, China

Location

Fourth Hospital of Hebei Medical University ( Site 3015)

Shijiazhuang, Hebei, 050035, China

Location

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

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital-henan cancer hospital ( Site 3002)

Zhengzhou, Henan, 450000, China

Location

Hubei Cancer Hospital ( Site 3012)

Wuhan, Hubei, 430079, China

Location

Xiangyang Central Hospital ( Site 3045)

Xiangyang, Hubei, 441106, China

Location

Hunan Cancer Hospital ( Site 3014)

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Soochow University ( Site 3040)

Suzhou, Jiangsu, 215006, China

Location

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

Nanchang, Jiangxi, 330006, China

Location

Jilin Province Tumor Hospital ( Site 3018)

Changchun, Jilin, 130000, China

Location

LinYi Cancer Hospital-Gastrology department ( Site 3024)

Linyi, Shandong, 276000, China

Location

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

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital,Fudan University-Oncology ( Site 3003)

Shanghai, Shanghai Municipality, 200032, China

Location

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

Shanghai, Shanghai Municipality, 200127, China

Location

West China Hospital, Sichuan University ( Site 3035)

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer hospital. ( Site 3030)

Chengdu, Sichuan, 610213, China

Location

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

Nanchong, Sichuan, 637199, China

Location

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

Ürümqi, Xinjiang, 830011, China

Location

Yunnan Province Cancer Hospital ( Site 3031)

Kunming, Yunnan, 650107, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang Cancer Hospital-Oncology ( Site 3021)

Hangzhou, Zhejiang, 310022, China

Location

Taizhou Hospital of Zhejiang Province ( Site 3020)

Linhai, Zhejiang, 317000, China

Location

Yueqing People's Hospital ( Site 3041)

Yueqing, Zhejiang, 325699, China

Location

Centro Cancerológico del Caribe (CECAC) ( Site 0606)

Barranquilla, Atlántico, 080001, Colombia

Location

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

Bogotá, Bogota D.C., 110131, Colombia

Location

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

Bogotá, Bogota D.C., 111321, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

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

Cali, Valle del Cauca Department, 760032, Colombia

Location

Rigshospitalet ( Site 1102)

Copenhagen, Capital Region, 2100, Denmark

Location

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

Aalborg, North Denmark, 9000, Denmark

Location

Odense Universitetshospital-Department of oncology ( Site 1101)

Odense, Region Syddanmark, 5000, Denmark

Location

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

Bordeaux, Aquitaine, 33076, France

Location

CENTRE LEON BERARD-Medical oncology ( Site 1208)

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

Centre François Baclesse ( Site 1202)

Caen, Calvados, 14076, France

Location

CHU Rangueil-Digestive oncology department ( Site 1210)

Toulouse, Haute-Garonne, 31059, France

Location

Centre Oscar Lambret ( Site 1206)

Lille, Hauts-de-France, 59020, France

Location

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

Rennes, Ille-et-Vilaine, 35042, France

Location

Centre Hospitalier Universitaire de Poitiers ( Site 1209)

Poitiers, Vienne, 86021, France

Location

Hôpital Saint-Louis ( Site 1201)

Paris, 75475, France

Location

Institut Mutualiste Montsouris-Oncology ( Site 1216)

Paris, Île-de-France Region, 75014, France

Location

NCT-Department of Medical Oncology ( Site 1302)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

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

Göttingen, Lower Saxony, 37075, Germany

Location

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

Dresden, Saxony, 01307, Germany

Location

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

Kiel, Schleswig-Holstein, 24116, Germany

Location

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

Berlin, 13353, Germany

Location

Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300)

Hamburg, 20249, Germany

Location

Queen Mary Hospital ( Site 3100)

Hong Kong, Hong Kong

Location

Prince of Wales Hospital ( Site 3102)

Shatin, Hong Kong

Location

Queen Elizabeth Hospital ( Site 3101)

Yau Ma Tei, 999077, Hong Kong

Location

Hillel Yaffe Medical Center ( Site 1604)

Hadera, 3810101, Israel

Location

Rambam Health Care Campus-Oncology Division ( Site 1600)

Haifa, 3109601, Israel

Location

Hadassah Medical Center ( Site 1603)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center ( Site 1605)

Petah Tikva, 4941492, Israel

Location

Sourasky Medical Center ( Site 1602)

Tel Aviv, 64239, Israel

Location

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

Naples, Campania, 80131, Italy

Location

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

Rome, Lazio, 00168, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

Azienda Ospedaliero Universitaria Pisana ( Site 1702)

Pisa, Tuscany, 56126, Italy

Location

Ospedale San Raffaele-Oncologia Medica ( Site 1701)

Milan, 20132, Italy

Location

Aichi Cancer Center ( Site 3307)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 3300)

Kashiwa, Chiba, 277-8577, Japan

Location

Kochi Medical School Hospital ( Site 3304)

Nankoku, Kochi, 783-8505, Japan

Location

Saitama Prefectural Cancer Center ( Site 3302)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Cancer Center Hospital ( Site 3301)

Chūō, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR ( Site 3306)

Koto, Tokyo, 135-8550, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 3303)

Fukuoka, 811-1395, Japan

Location

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

Osaka, 541-8567, Japan

Location

Hospital Pulau Pinang ( Site 3403)

George Town, Pulau Pinang, 10450, Malaysia

Location

National Cancer Institute-Radiotherapy and Oncology ( Site 3404)

Putrajaya, Putrajaya, 62250, Malaysia

Location

Sarawak General Hospital-Radiotherapy Unit ( Site 3401)

Kuching, Sarawak, 93586, Malaysia

Location

University Malaya Medical Centre-Clinical Oncology ( Site 3402)

Kuala Lumpur, 50603, Malaysia

Location

Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408)

Kuala Lumpur, 59100, Malaysia

Location

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

Guadalajara, Jalisco, 44260, Mexico

Location

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

Mexico City, Mexico City, 04700, Mexico

Location

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

Mexico City, Mexico City, 14080, Mexico

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 0810)

Oaxaca City, Oaxaca, 68020, Mexico

Location

Centro Potosino de Investigación Médica ( Site 0801)

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

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

Concepción, Departamento de Junín, 12125, Peru

Location

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

Trujillo, La Libertad, 13002, Peru

Location

Clínicas AUNA Sede Chiclayo ( Site 0907)

Chiclayo, Lambayeque, 14001, Peru

Location

Clínica Internacional - Sede San Borja ( Site 0906)

Lima, 15036, Peru

Location

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

Lima, 15036, Peru

Location

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

Lima, 15038, Peru

Location

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-034, Poland

Location

Bialostockie Centrum Onkologii ( Site 1804)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

Location

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

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

Szpital Wojewódzki w Koszalinie. ( Site 1801)

Poland, West Pomeranian Voivodeship, 75-581, Poland

Location

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

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Seoul National University Bundang Hospital ( Site 3504)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Seoul National University Hospital-Oncology ( Site 3503)

Seoul, 03080, South Korea

Location

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

Seoul, 03722, South Korea

Location

Asan Medical Center-Department of Oncology ( Site 3501)

Seoul, 05505, South Korea

Location

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

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

Hospital Universitario Marqués de Valdecilla ( Site 1901)

Santander, Cantabria, 39008, Spain

Location

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905)

A Coruña, La Coruna, 15006, Spain

Location

COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904)

Pamplona, Navarre, 31009, Spain

Location

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

Oviedo, Principality of Asturias, 33011, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos ( Site 1903)

Madrid, 28040, Spain

Location

China Medical University Hospital ( Site 3603)

Taichung, 404332, Taiwan

Location

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

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 3600)

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital ( Site 3601)

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 3602)

Taoyuan District, 33305, Taiwan

Location

Chulalongkorn University ( Site 3702)

Bangkok, Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 3700)

Bangkok, Bangkok, 10700, Thailand

Location

Songklanagarind hospital ( Site 3701)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

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

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)

Ankara, 06800, Turkey (Türkiye)

Location

Dicle Üniversitesi-oncology ( Site 2108)

Diyarbakır, 21100, Turkey (Türkiye)

Location

Atatürk Üniversitesi-onkoloji ( Site 2111)

Erzurum, 25070, Turkey (Türkiye)

Location

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

Istanbul, 34722, Turkey (Türkiye)

Location

Samsun Medical Park Hastanesi-medical oncology ( Site 2110)

Samsun, 55200, Turkey (Türkiye)

Location

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

Van, 65200, Turkey (Türkiye)

Location

Addenbrooke's Hospital ( Site 2203)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

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

Dundee, Dundee City, DD2 1SG, United Kingdom

Location

St Bartholomew's Hospital ( Site 2206)

London, London, City of, EC1A 7BE, United Kingdom

Location

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

Manchester, m20 4bx, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

trifluridine tipiracil drug combination; Irinotecan; Paclitaxel; Docetaxel

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (3); ES (6); CL (5); HK (3); CA (1); FR (9); PE (6); CO (5); TW (5); TU (8); DE (6); IT (5); TH (3); JP (8); CN (33); BE (4); IL (5); ME (6); PL (6); US (17); KR (6); BR (9); MY (5); GB (4)