Esophageal Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years at the time of signing the informed consent.
Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:

Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT05568095

Recruitment Status:

Recruiting

Sponsor:

Arcus Biosciences, Inc.

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There are 34 Locations for this study

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Genesis Cancer and Blood Institute
Hot Springs Arkansas, 71913, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles California, 90027, United States
Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
University of California Irvine Health Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica California, 90404, United States
Yale Cancer Center
New Haven Connecticut, 06250, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20007, United States
SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers Florida, 33901, United States
SCRI - Florida Cancer Specialists - North Region Research Office
Saint Petersburg Florida, 33705, United States
SCRI - Florida Cancer Specialists - Panhandle Research Office
Tallahassee Florida, 32308, United States
SCRI - Florida Cancer Specialists - East Region Research Office
West Palm Beach Florida, 33401, United States
University of Louisville James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Norton Cancer Institute - Poplar Level Road
Louisville Kentucky, 40217, United States
Ochsner Cancer Institute
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, 02109, United States
University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States
HealthPartners Cancer Center at Regions Hospital
Saint Louis Park Minnesota, 55426, United States
Perlmutter Cancer Center - 38th Street
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center - New York
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic - Taussig Cancer Center
Cleveland Ohio, 44106, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Mark H. Zangmeister Cancer Center
Columbus Ohio, 43219, United States
Providence Cancer Center Oncology and Hematology Care Westside Portland
Portland Oregon, 97225, United States
Prisma Health Cancer Insitute
Greenville South Carolina, 29615, United States
Tennessee Oncology - Chattanooga - Memorial Plaza
Nashville Tennessee, 37203, United States
Tennessee Oncology - Nashville - Centennial
Nashville Tennessee, 37203, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The Center for Cancer & Blood Disorders - Fort Worth
Fort Worth Texas, 76104, United States
Harris Health System
Houston Texas, 77054, United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax Virginia, 22031, United States
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
Seattle Washington, 98109, United States
Froedtert Clinical Cancer Center
Milwaukee Wisconsin, 53226, 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 More Info
Chi Pan Lau
Contact
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 , 50134, Italy
Instituto Europeo di Oncologia
Milano , 20141, 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
Instituto Nacional de Cancerologia - Mexico
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
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

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT05568095

Recruitment Status:

Recruiting

Sponsor:


Arcus Biosciences, Inc.

How clear is this clinincal trial information?

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