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
Public ClinicalTrials.gov record NCT05568095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05568095
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,040 participants
Conditions and interventions
Interventions
- Domvanalimab Drug
- Zimberelimab Drug
- Capecitabine Drug
- Fluorouracil Drug
- Leucovorin Drug
- Oxaliplatin Drug
- Nivolumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2022
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
- Last update posted
- Jul 30, 2026
2022 – 2026
United States locations
- U.S. sites
- 31
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | 90033 | — |
| Research Site | Orange | California | 92868 | — |
| Research Site | Santa Monica | California | 90404 | — |
| Research Site | New Haven | Connecticut | 06520 | — |
| Research Site | Washington D.C. | District of Columbia | 22057 | — |
| Research Site | Fort Myers | Florida | 33901 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Tallahassee | Florida | 32308 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Louisville | Kentucky | 40217 | — |
| Research Site | New Orleans | Louisiana | 70121 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Ann Arbor | Michigan | 48109 | — |
| Research Site | Saint Louis Park | Minnesota | 55426 | — |
| Research Site | Mineola | New York | 11501 | — |
| Research Site | New York | New York | 10016 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Durham | North Carolina | 27710 | — |
| Research Site | Cleveland | Ohio | 44106 | — |
| Research Site | Cleveland | Ohio | 44111 | — |
| Research Site | Columbus | Ohio | 43219 | — |
| Research Site | Mayfield Heights | Ohio | 44124 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Research Site | Dallas | Texas | 75390 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77054 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Seattle | Washington | 98109 | — |
| Research Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 136 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05568095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05568095 live on ClinicalTrials.gov.