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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 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. The trial reports 20 study locations across 11 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05568095
The ClinicalTrials.gov registry entry for NCT05568095 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,040 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcus Biosciences, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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