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
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 30 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
Thousand Oaks California, 91360, 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
Columbus Georgia, 31904, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40217, United States
New Orleans Louisiana, 70121, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Saint Louis Park Minnesota, 55426, United States
Omaha Nebraska, 68124, United States
New York New York, 10012, United States
New York New York, 10016, United States
New York New York, 10029, United States
Durham North Carolina, 27710, 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
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Fairfax Virginia, 22031, United States
Clayton , , Australia
Gosford , , Australia
Murdoch , , Australia
Kutaisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Tbilisi , , Georgia
Hong Kong , , Hong Kong
Kashiwa , , Japan
Koto-Ku , , Japan
Tokyo , , Japan
ÅŒsaka-sayama , , Japan
Vilnius , , Lithuania
Colonia Centro , , Mexico
Mexico City , , Mexico
Mérida , , Mexico
San Pedro Garza Garcia , , Mexico
Cluj-Napoca , , Romania
FloreÅŸti , , Romania
IaÅŸi , , Romania
London , , United Kingdom
How clear is this clinincal trial information?