Trials / Active Not Recruiting
Active Not RecruitingNCT05568095
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 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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,040 (actual)
- Sponsor
- Arcus Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Domvanalimab | Intravenous (IV) Aqueous Solution |
| DRUG | Zimberelimab | IV Aqueous Solution |
| DRUG | Capecitabine | Oral Tablets |
| DRUG | Fluorouracil | IV Aqueous Solution |
| DRUG | Leucovorin | IV Aqueous Solution |
| DRUG | Oxaliplatin | IV Aqueous Solution |
| DRUG | Nivolumab | IV Aqueous Solution |
Timeline
- Start date
- 2022-11-21
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2022-10-05
- Last updated
- 2026-04-02
Locations
210 sites across 29 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, France, Georgia, Guatemala, Hong Kong, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Serbia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05568095. Inclusion in this directory is not an endorsement.