Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06356311

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

473

Start Date

2024-05-03

Completion Date

2027-05-06

Last Updated

2026-10-22

Healthy Volunteers

Conditions

Gastroesophageal Cancer

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Docetaxel

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

DRUG

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.

DRUG

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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

James Lind Centro de Investigacion del Cancer ( Site 0506)

Temuco, Araucania, Chile

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

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

And 68 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (168)