Spots Global Cancer Trial Database for A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
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Trial Identification
Brief Title: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body
Official Title: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Study ID: NCT05568095
Study Description
Brief Summary: This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Genesis Cancer and Blood Institute, Hot Springs, Arkansas, United States
Kaiser Permanente - Los Angeles Medical Center, Los Angeles, California, United States
Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center, Orange, California, United States
UCLA Health - Santa Monica Cancer Care, Santa Monica, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
SCRI - Florida Cancer Specialists - South Region Research Office, Fort Myers, Florida, United States
SCRI - Florida Cancer Specialists - North Region Research Office, Saint Petersburg, Florida, United States
SCRI - Florida Cancer Specialists - Panhandle Research Office, Tallahassee, Florida, United States
SCRI - Florida Cancer Specialists - East Region Research Office, West Palm Beach, Florida, United States
University of Louisville James Graham Brown Cancer Center, Louisville, Kentucky, United States
Norton Cancer Institute - Poplar Level Road, Louisville, Kentucky, United States
Ochsner Cancer Institute, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
HealthPartners Cancer Center at Regions Hospital, Saint Louis Park, Minnesota, United States
Perlmutter Cancer Center - 38th Street, New York, New York, United States
Memorial Sloan Kettering Cancer Center - New York, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic - Taussig Cancer Center, Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Mark H. Zangmeister Cancer Center, Columbus, Ohio, United States
Providence Cancer Center Oncology and Hematology Care Westside Portland, Portland, Oregon, United States
Prisma Health Cancer Insitute, Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga - Memorial Plaza, Nashville, Tennessee, United States
Tennessee Oncology - Nashville - Centennial, Nashville, Tennessee, United States
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The Center for Cancer & Blood Disorders - Fort Worth, Fort Worth, Texas, United States
Harris Health System, Houston, Texas, United States
USOR - Virginia Cancer Specialists - Fairfax Office, Fairfax, Virginia, United States
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location, Seattle, Washington, United States
Froedtert Clinical Cancer Center, Milwaukee, Wisconsin, United States
Hospital Británico de Buenos Aires, Buenos Aires, , Argentina
CORI Centro Oncológico Riojano Integral, La Rioja, , Argentina
Instituto de Investigaciones Clínicas Mar del Plata, Mar Del Plata, , Argentina
Monash University, Clayton, , Australia
Gosford Hospital, Gosford, , Australia
Liverpool Hospital, Liverpool, , Australia
Oncology West - Murdoch, Murdoch, , Australia
Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor, Barretos, , Brazil
ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda., Ijuí, , Brazil
Liga Contra o Câncer - Centro Avançado de Oncologia, Natal, , Brazil
Hospital Ernesto Dornelles, Porto Alegre, , Brazil
Instituto Nacional de Câncer - Brazil, Rio De Janeiro, , Brazil
Queen Elizabeth II Health Sciences Centre-Victoria General, Charlottetown, , Canada
Ottawa Hospital - General Campus, Ottawa, , Canada
Hôpital Notre-Dame, Québec, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Sunnybrook Health Sciences Centre - Bayview Campus, Toronto, , Canada
Icegclinic, La Florida, , Chile
Oncovida - Santiago, Providencia, , Chile
Hospital Puerto Montt, Puerto Montt, , Chile
Bradford Hill Centro de Investigaciones Clinicas1, Recoleta, , Chile
Centro de Estudios Clínicos SAGA, Santiago, , Chile
Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq, Santiago, , Chile
Clínica Universidad Católica del Maule - Talca, Talca, , Chile
AnYang Tumor Hospital, Anyang, , China
The First People's Hospital of Changzhou, Changzhou, , China
900 Hospital of The Joint Logistic Support Force of PLA, Fuzhou, , China
Sun Yat-Sen University Cancer Center, Guangzhou, , China
Guangdong Provincial People's Hospital, Guanzhou, , China
Hainan General Hospital, Haikou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Provincial Hospital, Hefei, , China
The Second Hospital of Anhui Medical University, Hefei, , China
The First Affiliated Hospital of Henan Science and Technology University, Luoyang, , China
Shanghai East Hospital, Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Qinghai University Affiliated Hospital, Xining, , China
Henan Cancer Hospital, Zhengzhou, , China
Institut Bergonié, Bordeaux, , France
Hôpital Morvan, Brest, , France
Centre de Lutte contre le Cancer - François Baclesse, Caen, , France
Hôpital Claude Huriez, Lille, , France
Centre Léon Bérard, Lyon, , France
Hôpital de la Timone, Marseille, , France
Institut Régional du Cancer de Montpellier, Montpellier, , France
Centre Armoricain de Radiothérapie, d?Imagerie Médicale et d?Oncologie, Plérin, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Evex Hospitals - Kutaisi Referral Hospital, Kutaisi, , Georgia
LLC Todua Clinic, Tbilisi, , Georgia
Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi, , Georgia
Multi-profile Clinic "New Hospitals", Tbilisi, , Georgia
New Vision University Hospital, Tbilisi, , Georgia
Evgenidion Clinic SA - Agia Trias, Athens, , Greece
General Oncology Hospital of Kifisias "Agioi Anargyroi", Néa Kifisiá, , Greece
Metropolitan Hospital, Néo Fáliro, , Greece
BioClinic Thessaloniki, Thessaloníki, , Greece
Grupo Medico Angeles, Guatemala city, , Guatemala
Medi-k Cayalá, Guatemala city, , Guatemala
Clínica Privada Dr. Rixci Ramírez, Guatemala, , Guatemala
INTEGRA Cancer Institute, Guatemala, , Guatemala
Centro Regional de Sub Especialidades Médicas (CRESEM) SA, Quetzaltenango, , Guatemala
Hong Kong Sanatorium and Hospital, Happy Valley, , Hong Kong
Tuen Mun Hospital, Happy Valley, , Hong Kong
Humanity and Health Clinical Trial Centre, Hong Kong, , Hong Kong
Queen Mary Hospital - Hong Kong, Hong Kong, , Hong Kong
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Bács-Kiskun Megyei Oktatókórház - Kecskemét, Kecskemét, , Hungary
Pécsi Tudományegyetem Klinikai Központ, Pécs, , Hungary
Hadassah University Hospital Ein Kerem, Jerusalem, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Davidoff Cancer Center, Petah tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero - Universitaria Careggi, Firenze, , Italy
Instituto Europeo di Oncologia, Milano, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan, , Italy
Ospedale Santa Maria delle Croci di Ravenna, Ravenna, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia, Udine, , Italy
Hyogo Cancer Center, Akashi, , Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyō-Ku, , Japan
University of Tokyo Hospital, Bunkyō-Ku, , Japan
Chiba Cancer Center, Chiba, , Japan
Kyushu Cancer Center, Fukuoka, , Japan
National Cancer Center - Kashiwa Campus, Kashiwa, , Japan
St. Marianna University Hospital, Kawasaki, , Japan
Cancer Institute Hospital of JFCR, Koto-Ku, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Shikoku Cancer Center, Matsuyama, , Japan
Shizuoka Cancer Center, Nagaizumi-chō, , Japan
Aichi Cancer Center, Nagoya, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute, Osaka, , Japan
Saitama Cancer Center, Saitama, , Japan
Teine Keijinkai Hospital, Sapporo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Kanagawa Cancer Center, Yokohama, , Japan
Kindai University Hospital, Ōsaka-sayama, , Japan
Gunma Prefectural Cancer Center, Ōta, , Japan
Dong-A University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Cha Bundang Medical Center, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Kauno Klinikos, Kaunas, , Lithuania
Klaipedos Universitetine Ligonine, Klaipėda, , Lithuania
Nacionalinis Vėžio Institutas, Vilnius, , Lithuania
Vilniaus Universiteto Ligoninė Santariškių Klinikos, Vilnius, , Lithuania
Hospital Pulau Pinang, George Town, , Malaysia
Hospital Kuala Lumpur, Kuala Lumpur, , Malaysia
Pusat Perubatan Universiti Malaya, Kuala Lumpur, , Malaysia
Hospital Umum Sarawak, Kuching, , Malaysia
CLIMERS Clinical Medical Research, Colonia Centro, , Mexico
Centro Especializado en Investigacion y Tratamiento Oncologicos SC, Mexico City, , Mexico
Centro de Atención e Investigación Clínica en Oncología, Mérida, , Mexico
Hospital Zambrano Hellion TecSalud, San Pedro Garza Garcia, , Mexico
Centro Hemato - Oncológico Privado (CHOP), Toluca, , Mexico
SANNA - Clínica El Golf, San Isidro, , Peru
Hospital Maria Auxiliadora, San Juan De Miraflores, , Peru
Instituto Nacional de Enfermedades Neoplásicas, Surquillo, , Peru
Dr Pablo O. Torre Memorial Hospital - Riverside Medical Center, Bacolod, , Philippines
Baguio General Hospital and Medical Center, Baguio City, , Philippines
Cebu Doctors' University Hospital, Cebu, , Philippines
Manila Doctors Hospital, Manila, , Philippines
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
Szpital Miejski w Tychach, Tychy, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, , Poland
Centro Hospitalar e Universitário de Coimbra, Coimbra, , Portugal
Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud, Lisboa, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, Porto, , Portugal
Spitalul Judetean de Urgenta, Baia Mare, , Romania
Institutul Clinic Fundeni, Bucharest, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca, , Romania
Medisprof, Cluj-Napoca, , Romania
Centrul De Oncologie Sf Nectarie, Craiova, , Romania
Centrul de Radioterapie Amethyst Cluj, Floreşti, , Romania
Centrul de Oncologie Euroclinic, Iaşi, , Romania
Clinica SIGMedical, Suceava, , Romania
Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije), Belgrade, , Serbia
University Hospital Medical Center (KBC) Bezanijska Kosa, Belgrade, , Serbia
Clinical Center Kragujevac, Kragujevac, , Serbia
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Faculty of Medicine Siriraj Hospital, Bangkok Noi, , Thailand
Songklanagarind Hospital, Hat Yai, , Thailand
Sunpasitthiprasong Hospital, Mueang Nonthaburi, , Thailand
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Trakya Universitesi Tip Fakultesi, Edirne, , Turkey
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), İzmit, , Turkey
Kocaeli Üniversitesi Araştırma ve Uygulama Hastanesi, İzmit, , Turkey
Inönü Üniversitesi Turgut Özal Tıp Merkezi, Malatya, , Turkey
Ankara Üniversitesi Tıp Fakültesi - Cebeci Araştırma ve Uygulama Hastanesi, Mamak, , Turkey
Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi, Tuşba, , Turkey
Ataturk Universitesi Arastirma Hastanesi, Yakutiye, , Turkey
Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi, Yüreğir, , Turkey
Barts Health NHS Trust, London, , United Kingdom
Sarah Cannon Research Institute London, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
The Royal Marsden NHS Foundation Trust, Surrey Quays, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences
Role: STUDY_DIRECTOR
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