Spots Global Cancer Trial Database for A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
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Trial Identification
Brief Title: A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
Official Title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
Study ID: NCT05152147
Study Description
Brief Summary: This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital de Gastroenterología Dr Bonorino Udaondo, Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, , Argentina
Instituto de Investigaciones Metabólicas - IDIM, Ciudad Autónoma de Buenos Aires, , Argentina
Fundación Centro de Medicina Nuclear y Molecular ER, Córdoba, , Argentina
Centro Médico Privado CEMAIC, Córdoba, , Argentina
Centro de Investigación Pergamino S.A., Pergamino, , Argentina
Centro de Investigaciones Médicas Tucumán, San Miguel De Tucumán, , Argentina
Centro de Investigación Clínica - Clínica Viedma, Viedma, , Argentina
Border Medical Oncology Research Unit, Albury, , Australia
Flinders Medical Centre, Bedford Park, , Australia
Austin Health, Heidelberg, , Australia
Liverpool Hospital, Liverpool, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Imelda VZW, Bonheiden, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liège, Liège, , Belgium
Fundação Pio XII Hospital de Câncer de Barretos, Barretos, , Brazil
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto, Barretos, , Brazil
Cenantron - Centro Avancado de Tratamento Oncologico Ltda, Belo Horizonte, , Brazil
Hospital Amaral Carvalho, Brasília, , Brazil
Instituto Do Câncer Do Ceará ICC, Fortaleza, , Brazil
Associação Hospital de Caridade Ijuí, Ijuí, , Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre, , Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, , Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, , Brazil
Hospital Nossa Senhora Da Conceição, Porto Alegre, , Brazil
INCA - Instituto Nacional de Câncer José Alencar G, Rio De Janeiro, , Brazil
Instituto Brasileiro de Controle Do Câncer IBCC, Santo André, , Brazil
Instituto de Oncologia de Sorocaba, Sorocaba, , Brazil
Instituto do Cancer do Estado de São Paulo ICESP, São Paulo, , Brazil
Princess Margaret Cancer Centre, Toronto, , Canada
Fundación Arturo López Pérez (FALP) - PPDS, Providencia, Región-Metropolitana De Santiago, Chile
Corporacion de Beneficencia Osorno, Osorno, , Chile
Centro de Estudios Clínicos SAGA SpA, Providencia, , Chile
Meditek Ltda, Recoleta, , Chile
Sociedad Oncovida S.A, Santiago, , Chile
Icegclinic, Santiago, , Chile
BIOCINETIC SpA, Santiago, , Chile
James Lind Centro de Investigación del Cáncer, Temuco, , Chile
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Beijing Tiantan Hospital, Capital Medical University, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Beijing Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Beijing Luhe Hospital, Capital Medical University, Beijing, , China
The First Affiliated Hospital of Bengbu Medical College, Bengbu, , China
Hunan Cancer Hospital, Changsha, , China
Changzhi People's Hospital, Changzhi, , China
Changzhou First People's Hospital, Changzhou, , China
Sichuan Cancer Hospital & Institute, Chengdu, , China
Foshan First People's Hospital, Foshan, , China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, , China
Fujian Cancer Hospital, Fuzhou, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
Hainan General Hospital, Haikou, , China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, , China
Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Provincial Cancer Hospital, Hefei, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
Affiliated Hospital of Inner Mongolia Medical University, Hohhot, , China
Shandong Cancer Hospital, Jinan, , China
Jinan Central Hospital, Jinan, , China
Yunnan Cancer Hospital, Kunming, , China
The First Hospital of Lanzhou University, Lanzhou, , China
Gansu Cancer Hospital, Lanzhou, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School, Nanjing, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Ruijin hospital Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Fudan University Affiliated Zhongshan Hospital, Shanghai, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shanghai 10th People's Hospital, Shanghai, , China
Shanghai General Hospital, Shanghai, , China
Shanghai East Hospital, Shanghai, , China
Research Site 1, Shanghai, , China
Research Site 2, Shanghai, , China
Shangrao People's Hospital, Shangrao, , China
The First Hospital of China Medical University, Shenyang, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
Shenzehen People's Hospital, Shenzhen, , China
Peking University Shenzhen Hospital, Shenzhen, , China
Research Site, Shenzhen, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
Tianjin Medical University General Hospital, Tianjin, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
The Tonghua Central Hospital, Tonghua, , China
Weihai Municipal Hospital, Weihai, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Union Hospital Tongji Medical College HuaZhong University of Science and Technology, Wuhan, , China
Hubei Cancer Hospital, Wuhan, , China
Affiliated Hospital of Jiangnan University, Wuxi, , China
First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Northern Jiangsu People's Hospital, Yangzhou, , China
Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Cancer Hospital affiliated to Xinjiang Medical University, Ürümqi, , China
Fakultni nemocnice Olomouc, Hradec Králové, , Czechia
East Tallinn Central Hospital, Tallinn, , Estonia
North Estonia Medical Centre Foundation, Tallinn, , Estonia
Institut Sainte Catherine, Avignon, , France
Hopital Jean Minjoz, Besançon, , France
EDOG - Institut Bergonie - PPDS, Bordeaux, , France
Universite de Bourgogne - Faculte de Medecine - IN, Dijon, , France
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon, Grenoble, , France
Centre Léon Berard, Lyon, , France
EDOG Institut de Cancerologie de l'Ouest - PPDS, Nantes, , France
CHRU de Poitiers La Miletrie, Poitiers, , France
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS, Rennes, , France
CHRU de Brest - Hopital Morvan, Saint-Priest-en-Jarez, , France
Hôpital de Rangueil, Toulouse, , France
Hôpital Saint Antoine, Villejuif, , France
LTD TIM, Tbilisi Institute of Medicine, Tbilisi, , Georgia
Research Institute of Clinical Medicine, Tbilisi, , Georgia
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies, Tbilisi, , Georgia
High Technology Hospital MedCenter Ltd, Tbilisi, , Georgia
Institut für Klinisch-Onkologische Forschung, Frankfurt am Main, Hessen, Germany
Klinikum Mutterhaus der Borromäerinnen, Trier, Rheinland-Pfalz, Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Metaxa Memorial Cancer Hospital Piraeus Dept. οf Medical Oncology, Peiraias, Attiki, Greece
Aretaieio Hospital of Athens, Athens, , Greece
Attikon University General Hospital, Athens, , Greece
Research Site, Piraeus, , Greece
Bioclinic Thessaloniki Oncology Department, Thessaloniki, , Greece
Agios Loucas Clinic SA, Thessaloniki, , Greece
Interbalkan Medical Center of Thessaloniki Oncology Department, Thessaloniki, , Greece
Clinica Medica Especializada CELAN, Guatemala City, , Guatemala
Integra Cancer Institute, Guatemala City, , Guatemala
Grupo Medico Angeles, Guatemala City, , Guatemala
Centro Medico Integral de Cancerologia CEMIC, Salcaja, , Guatemala
The Bangalore Hospital, Bangalore, , India
All India Institute of Medical Sciences, Bhubaneswar, Bhubaneswar, , India
Artemis Hospital, Gurgaon, , India
MNJ Institute of Oncology and Regional Cancer Centre, Hyderabad, , India
Research Site, Jaipur, , India
Curie Manavata Cancer Centre, Nashik, , India
Indraprastha Apollo Hospitals, New Delhi, , India
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences, Patna, , India
Deenanath Mangeshkar Hospital and Research Centre, Pune, , India
HCG City Cancer Center, Vijayawada, , India
St James's Hospital, Dublin, , Ireland
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, , Italy
Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola, , Italy
Ospedale San Raffaele S.r.l. - PPDS, Milano, , Italy
Istituto Nazionale Dei Tumori, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda, Milano, , Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Fondazione Policlinico Universitario A Gemelli, Rome, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Centro Ricerche Cliniche Di Verona, Verona, , Italy
Azienda ULSS 8 "Berica" - Ospedale San Bortolo, Vicenza, , Italy
Gifu University Hospital, Gifu-Shi, Gihu, Japan
Gunma Prefectural Cancer Center, Ota-shi, Gunma, Japan
Fukui Prefectural Hospital, Fukui-shi, Hukui, Japan
Hyogo Cancer Center, Akashi-shi, Hyôgo, Japan
Kobe City Medical Center General Hospital, Kobe-Shi Chuo-Ku, Hyôgo, Japan
Ibaraki Prefectural Central Hospital, Kasama-Shi, Ibaraki, Japan
Kagawa University Hospital, Kita-Gun Miki-Cho, Kagawa, Japan
Kanagawa Cancer Center, Yokohama-Shi Asahi-Ku, Kanagawa, Japan
Kitasato University Hospital, Yokohama-Shi Minami-Ku, Kanagawa, Japan
Kumamoto University Hospital - Honjo-Kuhonji Campus A, Chuo-Ku, Kumamoto, Japan
Kyoto University Hospital, Sakyo-ku, Kyoto-shi, Japan
Osaki Citizen Hospital, Osaki-Shi, Miyagi, Japan
Kurashiki Central Hospital, Kurashiki-Shi, Okayama, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Osaka University Hospital, Suita-Shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital, Takatsuki-Shi, Osaka, Japan
Chiba Cancer Center, Chiba-Shi, Tiba, Japan
National Cancer Center Hospital East, Kashiwa-shi, Tiba, Japan
Keio University Hospital, Shinjuku-Ku, Tokyo, Japan
National Cancer Center Hospital, Chuo Ku, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, , Japan
Saitama Cancer Center, Ina, , Japan
Shikoku Cancer Center, Matsuyama, , Japan
Aichi Cancer Center, Nagoya shi, , Japan
Niigata Cancer Center Hospital, Niigata-shi, , Japan
Kindai University Hospital, Osaka-sayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Tokyo, , Japan
Hallym University Sacred Heart Hospital, Anyang-si, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Hospital Pulau Pinang, George Town, , Malaysia
Pantai Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Sarawak General Hospital, Kuching, , Malaysia
National Cancer Institute ( Institut Kanser Negara), Putrajaya, , Malaysia
Health Pharma Professional Research S.A de C.V., Mexico City, , Mexico
Cryptex Investigación Clínica, S.A. de C.V., Mexico City, , Mexico
Clinstile, S.A. de C.V., Mexico City, , Mexico
Hospital Universitario Dr. Jose Eleuterio González, Monterrey, , Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca, , Mexico
Catharina Hospital, Eindhoven, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
ETZ-Elisabeth, Tilburg, , Netherlands
Centrum Medyczne Poznan - PRATIA - PPDS, Skórzewo, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Łódź, , Poland
Hospital Garcia de Orta, Almada, , Portugal
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra, , Portugal
Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisboa, , Portugal
Hospital Beatriz Angelo, Loures, , Portugal
Unidade Local de Saúde de Matosinhos SA, Matosinhos, , Portugal
Centro Hospitalar do Porto EPE, Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto, , Portugal
Fundeni Clinical Institute, București, , Romania
Cardiomed SRL, Cluj-Napoca, , Romania
Prof Dr I Chiricuta Institute of Oncology - PPDS, Cluj-Napoca, , Romania
Medisprof SRL, Cluj-Napoca, , Romania
Onco Clinic Consult SA, Craiova, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Institute for Oncology and Radiology of Serbia - PPDS, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
University Clinical Center of Serbia - PPDS, Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa, Belgrade, , Serbia
University Clinical Center Nis, Niš, , Serbia
Oncology Institute of Vojvodina, Sremska Kamenica, , Serbia
Oncocare Cancer Centre, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Curie Oncology, Singapore, , Singapore
Cape Town Oncology Trials, Cape Town, , South Africa
Southern Cross Research South Africa (PTY) LTD, Mogale City, , South Africa
University of Pretoria, Pretoria, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Corporacio Sanitaria Parc Tauli, Sabadell, Barcelona, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital Universitari de Girona Dr Josep Trueta, Girona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz - PPDS, Madrid, , Spain
Hospital Regional Universitario de Malaga - Hospital General, Málaga, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
China Medical University Hospital, Taichung, , Taiwan
Chi Mei Medical Center, Tainan, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Siriraj Hospital Mahidol University, Bangkok Noi, , Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital, Bangkok, , Thailand
Phramongkutklao Hospital, Bangkok, , Thailand
Prince of Songkla University, Hat Yai, , Thailand
Srinagarind Hospital, Khon Kaen University, Khon Kaen, , Thailand
Chulaborn Hospital, Lak Si, , Thailand
Naresuan University, Phitsanulok, , Thailand
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Fatih, Istanbul, Turkey
Hacettepe Universitesi Kanser Enstitusu, Ankara, , Turkey
Akdeniz University Medical Faculty, Antalya, , Turkey
Antalya Yaşam Onkoloji Merkezi, Antalya, , Turkey
Research site, Balçova, , Turkey
Uludag Universites Tip Fakultesi Hastanesi, Bursa, , Turkey
Research site, Denizli, , Turkey
Dicle University Medical Faculty, Diyarbakir, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Research site, Fatih, , Turkey
Dokuz Eylul Universitesi, Izmir, , Turkey
Acibadem Maslak Hospital, Sariyer, , Turkey
Acibadem Adana Hospital, Seyhan, , Turkey
Research site, Sur, , Turkey
Research site, Tarabya, , Turkey
Medical Park Trabzon Yildizli, Trabzon, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkology Training and Research Hospital, Yenimahalle, , Turkey
Research site, Çankaya, , Turkey
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS, Dnipropetrovsk, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv, , Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council, Kryvyi Rih, , Ukraine
Medical Center of Limited Liability Company "Medical center "VERUM EXPERT", Kyiv, , Ukraine
Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima, Kyiv, , Ukraine
SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine, Kyiv, , Ukraine
Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center, Kyiv, , Ukraine
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council, Lutsk, , Ukraine
Daycare Facility of Dispensary-Polyclinic Department, Odesa, , Ukraine
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Western General Hospital Edinburgh - PPDS, Edinburgh, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London, , United Kingdom
Royal Marsden Hospital - London, London, , United Kingdom
Royal Marsden Hospital - Surrey, London, , United Kingdom
Mount Vernon Hospital, Northwood, , United Kingdom
Edith Cavell Hospital, Peterborough, , United Kingdom
Weston Park Cancer Centre, Sheffield, , United Kingdom
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