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Trial 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

NCT ID: NCT05568095

Condition: Advanced Upper Gastrointestinal Tract Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma
Leucovorin
Capecitabine
Fluorouracil
Nivolumab
Oxaliplatin

Conditions: Keywords:
Domvanalimab
Zimberelimab
Nivolumab
Advanced upper gastrointestinal tract adenocarcinoma
Gastroesophageal junction cancer
Esophageal adenocarcinoma
Gastric cancer
Gastric adenocarcinoma

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Domvanalimab
Description: Intravenous (IV) Aqueous Solution
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)

Other name: AB154

Intervention type: Drug
Intervention name: Zimberelimab
Description: IV Aqueous Solution
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)

Other name: AB122

Intervention type: Drug
Intervention name: Capecitabine
Description: Oral Tablets
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Arm group label: Nivolumab + FOLFOX/CAPOX (PI Choice)

Intervention type: Drug
Intervention name: Fluorouracil
Description: IV Aqueous Solution
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Arm group label: Nivolumab + FOLFOX/CAPOX (PI Choice)

Intervention type: Drug
Intervention name: Leucovorin
Description: IV Aqueous Solution
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Arm group label: Nivolumab + FOLFOX/CAPOX (PI Choice)

Intervention type: Drug
Intervention name: Oxaliplatin
Description: IV Aqueous Solution
Arm group label: Domvanalimab + Zimberelimab + FOLFOX/CAPOX (PI Choice)
Arm group label: Nivolumab + FOLFOX/CAPOX (PI Choice)

Intervention type: Drug
Intervention name: Nivolumab
Description: IV Aqueous Solution
Arm group label: Nivolumab + FOLFOX/CAPOX (PI Choice)

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.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - 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 status of 0-1. - At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key 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 completion of neoadjuvant or adjuvant therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Genesis Cancer Center and Blood Institute - Hot Springs

Address:
City: Hot Springs
Zip: 71913
Country: United States

Facility:
Name: Kaiser Permanente - Los Angeles Medical Center

Address:
City: Los Angeles
Zip: 90027
Country: United States

Facility:
Name: Norris Comprehensive Cancer Center

Address:
City: Los Angeles
Zip: 90033
Country: United States

Facility:
Name: University of California Irvine Health Chao Family Comprehensive Cancer Center

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: UCLA Health - Santa Monica Cancer Care

Address:
City: Santa Monica
Zip: 90404
Country: United States

Facility:
Name: Yale Cancer Center

Address:
City: New Haven
Zip: 06520
Country: United States

Facility:
Name: Georgetown Lombardi Comprehensive Cancer Center

Address:
City: Washington
Zip: 22057
Country: United States

Facility:
Name: SCRI - Florida Cancer Specialists - South Region Research Office

Address:
City: Fort Myers
Zip: 33901
Country: United States

Facility:
Name: SCRI - Florida Cancer Specialists - North Region Research Office

Address:
City: Saint Petersburg
Zip: 33705
Country: United States

Facility:
Name: SCRI - Florida Cancer Specialists - Panhandle Research Office

Address:
City: Tallahassee
Zip: 32308
Country: United States

Facility:
Name: SCRI - Florida Cancer Specialists - East Region Research Office

Address:
City: West Palm Beach
Zip: 33401
Country: United States

Facility:
Name: University of Louisville James Graham Brown Cancer Center

Address:
City: Louisville
Zip: 40202
Country: United States

Facility:
Name: Norton Cancer Institute - Poplar Level Road

Address:
City: Louisville
Zip: 40217
Country: United States

Facility:
Name: Ochsner Cancer Institute

Address:
City: New Orleans
Zip: 70121
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: University of Michigan Rogel Cancer Center

Address:
City: Ann Arbor
Zip: 48109
Country: United States

Facility:
Name: HealthPartners Cancer Center at Regions Hospital

Address:
City: Saint Louis Park
Zip: 55426
Country: United States

Facility:
Name: Perlmutter Cancer Center - 38th Street

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center - New York

Address:
City: New York
Zip: 10065
Country: United States

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27710
Country: United States

Facility:
Name: Cleveland Clinic - Taussig Cancer Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: University Hospitals Cleveland Medical Center

Address:
City: Cleveland
Zip: 44106
Country: United States

Facility:
Name: Providence Cancer Center Oncology and Hematology Care Westside Portland

Address:
City: Portland
Zip: 97225
Country: United States

Facility:
Name: Prisma Health Cancer Institute - Faris Road

Address:
City: Greenville
Zip: 29605
Country: United States

Facility:
Name: Tennessee Oncology - Chattanooga - Memorial Plaza

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: Tennessee Oncology - Nashville - Centennial

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Facility:
Name: The Center for Cancer & Blood Disorders - Fort Worth

Address:
City: Fort Worth
Zip: 76104
Country: United States

Facility:
Name: Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location

Address:
City: Seattle
Zip: 98109
Country: United States

Facility:
Name: Froedtert Clinical Cancer Center

Address:
City: Milwaukee
Zip: 53226
Country: United States

Facility:
Name: Hospital Británico de Buenos Aires

Address:
City: Buenos Aires
Country: Argentina

Facility:
Name: CORI Centro Oncológico Riojano Integral

Address:
City: La Rioja
Country: Argentina

Facility:
Name: Instituto de Investigaciones Clínicas Mar del Plata

Address:
City: Mar del Plata
Country: Argentina

Facility:
Name: Monash University

Address:
City: Clayton
Country: Australia

Facility:
Name: Gosford Hospital

Address:
City: Gosford
Country: Australia

Facility:
Name: Liverpool Hospital

Address:
City: Liverpool
Country: Australia

Facility:
Name: Oncology West - Murdoch

Address:
City: Murdoch
Country: Australia

Facility:
Name: Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor

Address:
City: Barretos
Country: Brazil

Facility:
Name: ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda.

Address:
City: Ijuí
Country: Brazil

Facility:
Name: Liga Contra o Câncer - Centro Avançado de Oncologia

Address:
City: Natal
Country: Brazil

Facility:
Name: Hospital Ernesto Dornelles

Address:
City: Porto Alegre
Country: Brazil

Facility:
Name: Instituto Nacional de Câncer - Brazil

Address:
City: Rio de Janeiro
Country: Brazil

Facility:
Name: Queen Elizabeth II Health Sciences Centre-Victoria General

Address:
City: Halifax
Country: Canada

Facility:
Name: Hôpital Notre-Dame

Address:
City: Montreal
Country: Canada

Facility:
Name: Ottawa Hospital - General Campus

Address:
City: Ottawa
Country: Canada

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Country: Canada

Facility:
Name: Sunnybrook Health Sciences Centre - Bayview Campus

Address:
City: Toronto
Country: Canada

Facility:
Name: Icegclinic

Address:
City: La Florida
Country: Chile

Facility:
Name: Oncovida - Santiago

Address:
City: Providencia
Country: Chile

Facility:
Name: Hospital Puerto Montt

Address:
City: Puerto Montt
Country: Chile

Facility:
Name: Bradford Hill Centro de Investigaciones Clinicas

Address:
City: Recoleta
Country: Chile

Facility:
Name: Centro de Estudios Clínicos SAGA

Address:
City: Santiago
Country: Chile

Facility:
Name: Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq

Address:
City: Santiago
Country: Chile

Facility:
Name: Clínica Universidad Católica del Maule - Talca

Address:
City: Talca
Country: Chile

Facility:
Name: AnYang Tumor Hospital

Address:
City: Anyang
Country: China

Facility:
Name: The First People's Hospital of Changzhou

Address:
City: Changzhou
Country: China

Facility:
Name: 900 Hospital of The Joint Logistic Support Force of PLA

Address:
City: Fuzhou
Country: China

Facility:
Name: Guangdong Provincial People's Hospital

Address:
City: Guangzhou
Country: China

Facility:
Name: Sun Yat-Sen University Cancer Center

Address:
City: Guangzhou
Country: China

Facility:
Name: Hainan General Hospital

Address:
City: Haikou
Country: China

Facility:
Name: Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Address:
City: Hangzhou
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Country: China

Facility:
Name: Harbin Medical University Cancer Hospital

Address:
City: Harbin
Country: China

Facility:
Name: Anhui Provincial Hospital

Address:
City: Hefei
Country: China

Facility:
Name: The Second Hospital of Anhui Medical University

Address:
City: Hefei
Country: China

Facility:
Name: The First Affiliated Hospital of Henan Science and Technology University

Address:
City: Luoyang
Country: China

Facility:
Name: Shanghai East Hospital

Address:
City: Shanghai
Country: China

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital

Address:
City: Tianjin
Country: China

Facility:
Name: Qinghai University Affiliated Hospital

Address:
City: Xining
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Country: China

Facility:
Name: Institut Bergonié

Address:
City: Bordeaux cedex
Country: France

Facility:
Name: Hôpital Morvan

Address:
City: Brest
Country: France

Facility:
Name: Centre de Lutte contre le Cancer - François Baclesse

Address:
City: Caen Cedex 5
Country: France

Facility:
Name: Hôpital Claude Huriez

Address:
City: Lille Cedex
Country: France

Facility:
Name: Centre Léon Bérard

Address:
City: Lyon
Country: France

Facility:
Name: Hôpital de la Timone

Address:
City: Marseille
Country: France

Facility:
Name: Institut Régional du Cancer de Montpellier

Address:
City: Montpellier
Country: France

Facility:
Name: Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie

Address:
City: Plerin
Country: France

Facility:
Name: Centre Hospitalier Universitaire de Poitiers

Address:
City: Poitiers
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif
Country: France

Facility:
Name: Evex Hospitals - Kutaisi Referral Hospital

Address:
City: Kutaisi
Zip: 4600
Country: Georgia

Facility:
Name: LLC Todua Clinic

Address:
City: Tbilisi
Zip: 0112
Country: Georgia

Facility:
Name: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Address:
City: Tbilisi
Zip: 0144
Country: Georgia

Facility:
Name: New Vision University Hospital

Address:
City: Tbilisi
Zip: 0159
Country: Georgia

Facility:
Name: Multi-profile Clinic "New Hospitals"

Address:
City: Tbilisi
Zip: 0186
Country: Georgia

Facility:
Name: Evgenidion Clinic SA - Agia Trias

Address:
City: Athens
Country: Greece

Facility:
Name: General Oncology Hospital of Kifisias "Agioi Anargyroi"

Address:
City: Nea Kifisia
Country: Greece

Facility:
Name: Metropolitan Hospital

Address:
City: Neo Faliro
Country: Greece

Facility:
Name: Medi-k Cayalá

Address:
City: Guatemala city
Country: Guatemala

Facility:
Name: Clínica Privada Dr. Rixci Ramírez

Address:
City: Guatemala
Country: Guatemala

Facility:
Name: Grupo Medico Angeles

Address:
City: Guatemala
Country: Guatemala

Facility:
Name: INTEGRA Cancer Institute

Address:
City: Guatemala
Country: Guatemala

Facility:
Name: Centro Regional de Sub Especialidades Médicas (CRESEM) SA

Address:
City: Quetzaltenango
Country: Guatemala

Facility:
Name: Hong Kong Sanatorium and Hospital

Address:
City: Happy Valley
Country: Hong Kong

Facility:
Name: Humanity & Health Clinical Trial Centre

Address:
City: Hong Kong
Country: Hong Kong

Facility:
Name: Tuen Mun Hospital

Address:
City: Tuen Mun
Country: Hong Kong

Facility:
Name: Pécsi Tudományegyetem Klinikai Központ

Address:
City: Pecs
Country: Hungary

Facility:
Name: Davidoff Cancer Center

Address:
City: Petah Tikva
Country: Israel

Facility:
Name: Tel Aviv Sourasky Medical Center

Address:
City: Tel Aviv
Country: Israel

Facility:
Name: Azienda Ospedaliero - Universitaria Careggi

Address:
City: Firenze
Country: Italy

Facility:
Name: Istituto Europeo di Oncologia

Address:
City: Milano
Country: Italy

Facility:
Name: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

Address:
City: Milan
Country: Italy

Facility:
Name: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Address:
City: Rozzano
Country: Italy

Facility:
Name: Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia

Address:
City: Udine
Country: Italy

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi City
Country: Japan

Facility:
Name: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Address:
City: Bunkyo-ku
Country: Japan

Facility:
Name: University of Tokyo Hospital

Address:
City: Bunkyo-ku
Country: Japan

Facility:
Name: Chiba Cancer Center

Address:
City: Chiba
Country: Japan

Facility:
Name: Kyushu Cancer Center

Address:
City: Fukuoka-shi
Country: Japan

Facility:
Name: National Cancer Center - Kashiwa Campus

Address:
City: Kashiwa
Country: Japan

Facility:
Name: St. Marianna University Hospital

Address:
City: Kawasaki-Shi
Country: Japan

Facility:
Name: Cancer Institute Hospital of JFCR

Address:
City: Koto
Country: Japan

Facility:
Name: Kumamoto University Hospital

Address:
City: Kumamoto
Country: Japan

Facility:
Name: Shikoku Cancer Center

Address:
City: Matsuyama-Shi
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Nagaizumi
Country: Japan

Facility:
Name: Aichi Cancer Center

Address:
City: Nagoya
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osaka
Country: Japan

Facility:
Name: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Address:
City: Osaka
Country: Japan

Facility:
Name: Gunma Prefectural Cancer Center

Address:
City: Ota-Shi
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Saitama
Country: Japan

Facility:
Name: National Cancer Center Hospital

Address:
City: Tokyo
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama-shi
Country: Japan

Facility:
Name: Dong-A University Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Cha Bundang Medical Center

Address:
City: Seongnam-si
Country: Korea, Republic of

Facility:
Name: Asan Medical Center