drugset / Trial / NCT05568095
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
Phase 3
Active not recruiting
1040 enrolled
Arcus Biosciences, Inc.
Gilead Sciences · collabTaiho Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-11-21
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Domvanalimab | Monoclonal antibody | — | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Zimberelimab | Monoclonal antibody | — | Intravenous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Oxaliplatin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |