Clinical Trial

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

Study acronym: STAR-221
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-06 -> 2026-08 2026-07-22
minor Completion pushed: 2026-06 -> 2026-08 2026-07-22
notable Trial sites reduced: 210 -> 170 locations 2026-05-09
Trial Details
NCT Number NCT05568095
Lead Sponsor Arcus Biosciences, Inc.
Collaborators: Gilead Sciences, Taiho Pharmaceutical Co., Ltd.
Conditions Advanced Upper Gastrointestinal Tract Adenocarcinoma
Enrollment 1,040 participants
Start Date 2022-11-21
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-31