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 30 Locations for this study

See Locations Near You

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
Millennium Reasearch & Clinical Development'
Thousand Oaks California, 91360, 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
Centricity Research
Columbus Georgia, 31904, United States
University of Louisville James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Norton Cancer Institute
Louisville Kentucky, 40217, United States
Ochsner Cancer Institute
New Orleans Louisiana, 70121, United States
University of Michigan Rogel Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
HealthPartners Cancer Center at Regions Hospital
Saint Louis Park Minnesota, 55426, United States
Nebraska Cancer Specialists - Oncology Hematology West PC
Omaha Nebraska, 68124, United States
NYU Langone Hospital
New York New York, 10012, United States
Albert Einstein College of Medicine
New York New York, 10016, United States
Tisch Cancer Institute, Mount Sinai Hospital
New York New York, 10029, United States
Duke University Medical Center
Durham North Carolina, 27710, 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
SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza
Nashville Tennessee, 37203, United States
SCRI - Tennessee Oncology - Nashville - Centennial
Nashville Tennessee, 37203, 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
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax Virginia, 22031, United States
Monash University
Clayton , , Australia
Gosford Hospital
Gosford , , Australia
Oncology West - Murdoch
Murdoch , , Australia
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
New Vision University Hospital
Tbilisi , , Georgia
Queen Mary Hospital - Hong Kong
Hong Kong , , Hong Kong
National Cancer Center - Kashiwa Campus
Kashiwa , , Japan
Cancer Institute Hospital of JFCR
Koto-Ku , , Japan
National Cancer Center Hospital
Tokyo , , Japan
Kindai University Hospital
ÅŒsaka-sayama , , Japan
Nacionalinis Vėžio Institutas
Vilnius , , Lithuania
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
Medisprof
Cluj-Napoca , , Romania
Centrul de Radioterapie Amethyst Cluj
FloreÅŸti , , Romania
Centrul de Oncologie Euroclinic
IaÅŸi , , Romania
Sarah Cannon Research Institute London
London , , 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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