Study on New Combination Treatment with Domvanalimab, Zimberelimab, and Chemotherapy for Advanced Upper Gastrointestinal Tract Cancer
Sponsor: Arcus Biosciences, Inc.
ClinicalTrials ID:NCT05568095
This clinical trial is testing a new combination of two immunotherapy drugs, Domvanalimab and Zimberelimab, along with chemotherapy, to treat advanced upper gastrointestinal tract cancers that cannot be removed by surgery and have spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness of a new treatment combination, which includes the immunotherapy drugs Domvanalimab and Zimberelimab plus chemotherapy, against the standard treatment of Nivolumab plus chemotherapy. This study is for patients with advanced gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma that cannot be surgically removed or has spread to other areas.
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent and agree to the study requirements.
- Diagnosed with advanced gastric, GEJ, or esophageal adenocarcinoma that cannot be removed by surgery or has spread.
- In good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one tumor that can be measured using standard criteria.
Exclusion Criteria
- Have medical or mental health conditions that could make the study treatment unsafe.
- Have lung diseases like interstitial lung disease or pneumonitis.
- Have active infections needing treatment within 14 days before starting the study.
- Have serious heart conditions or recent heart attacks.
- Have had an organ transplant or bone marrow transplant.
- Have dementia or substance abuse issues that could interfere with the study.
- Have a HER-2 positive tumor.
- Have untreated or worsening brain metastases.
- Have received previous treatment for advanced gastric, GEJ, or esophageal adenocarcinoma.
- Have cancer that progressed within 6 months after completing previous therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Genesis Cancer Center and Blood Institute - Hot Springs | 71913 | Hot Springs | Arkansas |
| Kaiser Permanente - Los Angeles Medical Center | 90027 | Los Angeles | California |
| Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of California Irvine Health Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UCLA Health - Santa Monica Cancer Care | 90404 | Santa Monica | California |
| Yale Cancer Center | 06520 | New Haven | Connecticut |
| Georgetown Lombardi Comprehensive Cancer Center | 22057 | Washington D.C. | District of Columbia |
| SCRI - Florida Cancer Specialists - South Region Research Office | 33901 | Fort Myers | Florida |
| SCRI - Florida Cancer Specialists - North Region Research Office | 33705 | St. Petersburg | Florida |
| SCRI - Florida Cancer Specialists - Panhandle Research Office | 32308 | Tallahassee | Florida |
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