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.
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.
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There are 34 Locations for this study
Hot Springs Arkansas, 71913, United States
Los Angeles California, 90027, United States
Los Angeles California, 90033, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
New Haven Connecticut, 06250, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
West Palm Beach Florida, 33401, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40217, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02109, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Park Minnesota, 55426, United States
New York New York, 10016, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97225, United States
Greenville South Carolina, 29615, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77054, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Buenos Aires , , Argentina
La Rioja , , Argentina
Mar Del Plata , , Argentina
Clayton , , Australia
Gosford , , Australia
Liverpool , , Australia
Murdoch , , Australia
Barretos , , Brazil
Ijuí , , Brazil
Natal , , Brazil
Porto Alegre , , Brazil
Rio De Janeiro , , Brazil
Charlottetown , , Canada
Ottawa , , Canada
Québec , , Canada
Toronto , , Canada
Toronto , , Canada
La Florida , , Chile
Providencia , , Chile
Puerto Montt , , Chile
Recoleta , , Chile
Santiago , , Chile
Santiago , , Chile
Talca , , Chile
Anyang , , China
Changzhou , , China
Fuzhou , , China
Guangzhou , , China
Guanzhou , , China
Haikou , , China
Hangzhou , , China
Hangzhou , , China
Harbin , , China
Hefei , , China
Hefei , , China
Luoyang , , China
Shanghai , , China
Tianjin , , China
Xining , , China
Zhengzhou , , China
Bordeaux , , France
Brest , , France
Caen , , France
Lille , , France
Lyon , , France
Marseille , , France
Montpellier , , France
Plérin , , France
Poitiers , , France
Toulouse , , France
Villejuif , , France
Kutaisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Athens , , Greece
Néa Kifisiá , , Greece
Néo Fáliro , , Greece
Thessaloníki , , Greece
Guatemala city , , Guatemala
Guatemala city , , Guatemala
Guatemala , , Guatemala
Guatemala , , Guatemala
Quetzaltenango , , Guatemala
Happy Valley , , Hong Kong
Happy Valley , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Budapest , , Hungary
Budapest , , Hungary
Kecskemét , , Hungary
Pécs , , Hungary
Jerusalem , , Israel
Jerusalem , , Israel
Petah tikva , , Israel
Tel Aviv , , Israel
Firenze , 50134, Italy
Milano , 20141, Italy
Milan , , Italy
Ravenna , , Italy
Rozzano , , Italy
Udine , , Italy
Akashi , , Japan
Bunkyō-Ku , , Japan
Bunkyō-Ku , , Japan
Chiba , , Japan
Fukuoka , , Japan
Kashiwa , , Japan
Kawasaki , , Japan
Koto-Ku , , Japan
Kumamoto , , Japan
Matsuyama , , Japan
Nagaizumi-chō , , Japan
Nagoya , , Japan
Niigata , , Japan
Osaka , , Japan
Saitama , , Japan
Sapporo , , Japan
Tokyo , , Japan
Yokohama , , Japan
Ōsaka-sayama , , Japan
Ōta , , Japan
Busan , , Korea, Republic of
Daegu , , Korea, Republic of
Seongnam-si , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Kaunas , , Lithuania
Klaipėda , , Lithuania
Vilnius , , Lithuania
Vilnius , , Lithuania
George Town , , Malaysia
Kuala Lumpur , , Malaysia
Kuala Lumpur , , Malaysia
Kuching , , Malaysia
Colonia Centro , , Mexico
Mexico City , , Mexico
Mérida , , Mexico
San Pedro Garza Garcia , , Mexico
Toluca , , Mexico
San Isidro , , Peru
San Juan De Miraflores , , Peru
Surquillo , , Peru
Bacolod , , Philippines
Baguio City , , Philippines
Cebu , , Philippines
Manila , , Philippines
Lublin , , Poland
Lublin , , Poland
Tychy , , Poland
Warszawa , , Poland
Coimbra , , Portugal
Lisboa , , Portugal
Porto , , Portugal
Baia Mare , , Romania
Bucharest , , Romania
Cluj-Napoca , , Romania
Cluj-Napoca , , Romania
Craiova , , Romania
Floreşti , , Romania
Iaşi , , Romania
Suceava , , Romania
Belgrade , , Serbia
Belgrade , , Serbia
Kragujevac , , Serbia
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Santander , , Spain
Valencia , , Spain
Zaragoza , , Spain
Bangkok Noi , , Thailand
Hat Yai , , Thailand
Mueang Nonthaburi , , Thailand
Adana , , Turkey
Ankara , , Turkey
Edirne , , Turkey
Istanbul , , Turkey
İzmit , , Turkey
İzmit , , Turkey
Malatya , , Turkey
Mamak , , Turkey
Tuşba , , Turkey
Yakutiye , , Turkey
Yüreğir , , Turkey
London , , United Kingdom
London , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Oxford , , United Kingdom
Surrey Quays , , United Kingdom
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