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 11 Locations for this study

See Locations Near You

Genesis Cancer and Blood Institute
Hot Springs Arkansas, 71913, 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
Norton Cancer Institute
Louisville Kentucky, 40217, United States
HealthPartners Cancer Center at Regions Hospital
Saint Louis Park Minnesota, 55426, United States
Mark H. Zangmeister Cancer Center
Columbus Ohio, 43219, 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
The Center for Cancer & Blood Disorders - Fort Worth
Fort Worth Texas, 76104, United States

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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