Clinical trial NCT06356311: A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastroesophageal Cancer
Keywords: Gastroesophageal cancer
Gastroesophageal adenocarcinoma
Gastric adenocarcinoma
Esophageal adenocarcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-04-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 adequate organ function
* 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 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 measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology
* 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 a trophoblast antigen 2(TROP2) targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor based, 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 hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
* 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 severe hypersensitivity (Grades \>=3) to the study interventions, any of their excipients, and/or to another biologic therapy
* Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~ 31 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to ~ 25 months
measure: Objective Response Rate (ORR)
timeFrame: Up to ~ 25 months
measure: Duration of Response (DOR)
timeFrame: Up to ~ 48 months
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~ 48 months
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to ~ 48 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center ( Site 0119)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0140)
state: California
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0120)
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124)
state: Kentucky
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113)
state: Kentucky
city: Louisville
country: United States
facility: Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105)
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0107)
state: Michigan
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138)
state: North Dakota
city: Portland
country: United States
facility: Oregon Health and Science University ( Site 0104)
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 0126)
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0136)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 0110)
state: Tennessee
city: Fairfax
country: United States
facility: Inova Schar Cancer ( Site 0106)
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center ( Site 0111)
state: Washington
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003)
state: Bruxelles-Capitale, Region De
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001)
state: Bruxelles-Capitale, Region De
city: Leuven
country: Belgium
facility: UZ Leuven-Digestive Oncology ( Site 1000)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta vzw ( Site 1002)
state: West-Vlaanderen
city: Fortaleza
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405)
state: Ceara
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijuí ( Site 0412)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0400)
state: Rio Grande Do Sul
city: Joinville
country: Brazil
facility: Centro de Hematologia e Oncologia ( Site 0404)
state: Santa Catarina
city: Barretos.
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0401)
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0411)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 0409)
city: Sao Paulo
country: Brazil
facility: IBCC - Núcleo de Pesquisa e Ensino ( Site 0402)
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0201)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 0506)
state: Araucania
city: Santiago.
country: Chile
facility: Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503)
state: Region M. De Santiago
city: Santiago.
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0501)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0500)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital-medical oncology ( Site 3016)
state: Anhui
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038)
state: Anhui
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital ( Site 3036)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital ( Site 3007)
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Logistics Support Force of PLA ( Site 3008)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-oncology ( Site 3011)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 3013)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yatsen University Cancer Center ( Site 3001)
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College ( Site 3034)
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047)
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University ( Site 3015)
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3005)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-henan cancer hospital ( Site 3002)
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 3012)
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital ( Site 3045)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3014)
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University ( Site 3040)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3037)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital ( Site 3018)
state: Jilin
city: Linyi
country: China
facility: LinYi Cancer Hospital-Gastrology department ( Site 3024)
state: Shandong
city: Shangai
country: China
facility: Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3042)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-medical oncology ( Site 3009)
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University-Oncology ( Site 3003)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 3030)
state: Sichuan
city: Chengdú
country: China
facility: West China Hospital, Sichuan University ( Site 3035)
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital (Jiangdong Campus) ( Site 3029)
state: Sichuan
city: Urumchi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumchi-The No.11 of Surgery building ( Site 3010)
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 3031)
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Oncology ( Site 3021)
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 3020)
state: Zhejiang
city: Yueqing
country: China
facility: Yueqing People's Hospital ( Site 3041)
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Centro Cancerológico del Caribe (CECAC) ( Site 0606)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0600)
state: Cesar
city: Bogota
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0602)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundación Valle del Lili-Fundacion Valle del Lili ( Site 0607)
state: Valle Del Cauca
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 1102)
state: Hovedstaden
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103)
state: Nordjylland
city: Odense
country: Denmark
facility: Odense Universitetshospital-Department of oncology ( Site 1101)
state: Syddanmark
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211)
state: Aquitaine
city: Caen
country: France
facility: Centre François Baclesse ( Site 1202)
state: Calvados
city: Toulouse
country: France
facility: CHU Rangueil-Digestive oncology department ( Site 1210)
state: Haute-Garonne
city: Paris
country: France
facility: Institut Mutualiste Montsouris-Oncology ( Site 1216)
state: Ile-de-France
city: Rennes
country: France
facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203)
state: Ille-et-Vilaine
city: Lille
country: France
facility: Centre Oscar Lambret ( Site 1206)
state: Nord-Pas-de-Calais
city: Lyon
country: France
facility: CENTRE LEON BERARD-Medical oncology ( Site 1208)
state: Rhone-Alpes
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers ( Site 1209)
state: Vienne
city: Paris
country: France
facility: Hôpital Saint-Louis ( Site 1201)
city: Heidelberg
country: Germany
facility: NCT-Department of Medical Oncology ( Site 1302)
state: Baden-Wurttemberg
city: Gotinga
country: Germany
facility: Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1310)
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 1307)
state: Sachsen
city: Kiel
country: Germany
facility: Städtisches Krankenhaus Kiel-2. Medizinische Klinik ( Site 1306)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 1304)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 3100)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 3102)
city: Yau Ma Tei
country: Hong Kong
facility: Queen Elizabeth Hospital ( Site 3101)
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center ( Site 1604)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1600)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1603)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1605)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1602)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1704)
state: Campania
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700)
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana ( Site 1702)
state: Toscana
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1701)
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 3307)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 3300)
state: Chiba
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital ( Site 3304)
state: Kochi
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 3302)
state: Saitama
city: Chuo
country: Japan
facility: National Cancer Center Hospital ( Site 3301)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 3306)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 3303)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3305)
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 3504)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Oncology ( Site 3503)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Oncology ( Site 3501)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 3502)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505)
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 3403)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 3401)
state: Sarawak
city: Putrajaya
country: Malaysia
facility: National Cancer Institute-Radiotherapy and Oncology ( Site 3404)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre-Clinical Oncology ( Site 3402)
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408)
city: Mexico City
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 0802)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0814)
state: Jalisco
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0810)
state: Oaxaca
city: San Luis Potosí
country: Mexico
facility: Centro Potosino de Investigación Médica ( Site 0801)
state: San Luis Potosi
city: Concepcion
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904)
state: Junin
city: Trujillo
country: Peru
facility: Hospital de Alta Complejidad La Libertad-Unidad de Investigación en Oncología ( Site 0902)
state: La Libertad
city: Chiclayo
country: Peru
facility: Clínicas AUNA Sede Chiclayo ( Site 0907)
state: Lambayeque
city: Lima
country: Peru
facility: Clínica Internacional - Sede San Borja ( Site 0906)
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0900)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1800)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 1804)
state: Podlaskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej " Profil Jednego Dnia " ( Site 1810)
state: Pomorskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811)
state: Swietokrzyskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1801)
state: Zachodniopomorskie
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902)
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla ( Site 1901)
state: Cantabria
city: A Coruna
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905)
state: La Coruna
city: Pamplona
country: Spain
facility: COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904)
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos ( Site 1903)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 3603)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3600)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 3601)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3602)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 3702)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 3700)
state: Krung Thep Maha Nakhon
city: Hat Yai
country: Thailand
facility: Songklanagarind hospital ( Site 3701)
state: Songkhla
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2104)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101)
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi-oncology ( Site 2108)
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi-onkoloji ( Site 2111)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2106)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 2110)
city: Van
country: Turkey
facility: Yuzuncu Yil University Dursun Odaba Tp Merkezi-Medical Oncology ( Site 2109)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 2203)
state: Cambridgeshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School-Oncology Petty ( Site 2209)
state: Dundee City
city: London
country: United Kingdom
facility: St Bartholomew's Hospital ( Site 2206)
state: London, City Of
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust-Medical Oncology ( Site 2201)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: