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NCT05568095 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Advanced Upper Gastrointestinal Tract Adenocarcinoma, sponsored by Arcus Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 1,040
- Enrollment target
- 20
- Study locations
NCT05568095: Active Phase 3 study of Advanced Upper Gastrointestinal Tract Adenocarcinoma, sponsored by Arcus Biosciences.
NCT05568095 is a Phase 3 study of Advanced Upper Gastrointestinal Tract Adenocarcinoma that is active but no longer recruiting, run by Arcus Biosciences. The registered enrollment target is 1,040 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05568095, a Phase 3 study of Advanced Upper Gastrointestinal Tract Adenocarcinoma, is active but no longer recruiting, sponsored by Arcus Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,040 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Zimberelimab
- DRUG Domvanalimab
Study Locations (20)
California
- Kaiser Permanente - Los Angeles Medical Center - Los Angeles
- Norris Comprehensive Cancer Center - Los Angeles
- University of California Irvine Health Chao Family Comprehensive Cancer Center - Orange
- UCLA Health - Santa Monica Cancer Care - Santa Monica
Florida
- SCRI - Florida Cancer Specialists - South Region Research Office - Fort Myers
- SCRI - Florida Cancer Specialists - North Region Research Office - St. Petersburg
- SCRI - Florida Cancer Specialists - Panhandle Research Office - Tallahassee
- SCRI - Florida Cancer Specialists - East Region Research Office - West Palm Beach
Kentucky
- University of Louisville James Graham Brown Cancer Center - Louisville
- Norton Cancer Institute - Poplar Level Road - Louisville
Minnesota
- HealthPartners Cancer Center at Regions Hospital - Saint Louis Park
- Regions Hospital - Saint Louis Park
New York
- Perlmutter Cancer Ctr NYU - Mineola
- Perlmutter Cancer Center - 38th Street - New York
Arkansas
- Genesis Cancer Center and Blood Institute - Hot Springs - Hot Springs
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,040 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What the registry record for NCT05568095 still lists
NCT05568095 is an interventional study that assigns participants to a tested intervention. Its 1,040 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Advanced Upper Gastrointestinal Tract Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05568095 names 20 study sites across 11 states, led by California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT05568095 about?
NCT05568095 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05568095?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,040 participants. The study started on 2022-11-21. Estimated completion is 2026-06.
What conditions does trial NCT05568095 study?
This clinical trial studies the following conditions: Advanced Upper Gastrointestinal Tract Adenocarcinoma.
What interventions are being tested in trial NCT05568095?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Zimberelimab (DRUG), Domvanalimab (DRUG).
Who is sponsoring clinical trial NCT05568095?
This trial is sponsored by Arcus Biosciences, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05568095 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05568095's enrollment target sits among peer trials
1,040 285th of 2000 higher than 1,715 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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