> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-of-a-new-combination-treatment-domvanalimab-855f2af6-2909-4db2-a114-5887eeab4af4 > Record changed: 2026-10-13 # 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 NCT05568095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Participants 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Lead sponsor Arcus Biosciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Start date 2022-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) Number of sites 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Acronym** STAR-221 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Dates **Completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **First posted** 2022-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Primary completion date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Start date** 2022-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Size and sites **Actual participants** 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Participants** 1,040 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Number of sites** 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Lead sponsor** Arcus Biosciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Identifiers **Registry ID** NCT05568095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **ClinicalTrials.gov ID** NCT05568095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Outcomes ### Primary outcomes 1. Overall survival Timeframe: From date of randomization until date of death from any cause (Approximately 15 months)\] ### Secondary outcomes 1. Progression-free survival (PFS) Timeframe: From date of randomization to date of the first documentation of disease progression or date of death from any cause, whichever comes first (Approximately 15 months) 2. Objective response rate (ORR) Timeframe: Proportion of randomized participants who achieved a confirmed best overall response of complete response (CR) or partial response (PR) (Approximately 15 months) 3. Duration of response (DOR) Timeframe: From the date of first confirmed response (CR or PR), until the date of first documented disease progression or date of death from any cause, whichever comes first (Approximately 15 months) 4. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Timeframe: From on or after the date of first dose of any study treatment to the date of last study treatment specific safety follow-up or date of initiation of subsequent systemic anti-cancer therapy, whichever occurs first (Approximately 15 months) 5. Time to first symptom deterioration in the FACT-Ga gastric cancer subscale. Timeframe: From the date of randomization to change from baseline in subscale greater than or equal to the deterioration threshold, or death from any cause, whichever comes first (Approximately 15 months) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol. - Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key Exclusion Criteria: - Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to: - Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization. - Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization. - History of prior solid-organ transplantation, including allogenic bone marrow transplantation. - Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial. - Known human epidermal growth factor receptor 2 (HER-2) positive tumor. - Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment. - Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma. - Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Sites - Research SiteLos Angeles, United States - Research SiteOrange, United States - Research SiteSanta Monica, United States - Research SiteNew Haven, United States - Research SiteWashington D.C., United States - Research SiteFort Myers, United States - Research SiteSt. Petersburg, United States - Research SiteTallahassee, United States - Research SiteLouisville, United States - Research SiteLouisville, United States - Research SiteNew Orleans, United States - Research SiteBoston, United States - Research SiteAnn Arbor, United States - Research SiteSaint Louis Park, United States - Research SiteMineola, United States - Research SiteNew York, United States - Research SiteNew York, United States - Research SiteDurham, United States - Research SiteCleveland, United States - Research SiteCleveland, United States - Research SiteColumbus, United States - Research SiteMayfield Heights, United States - Research SitePortland, United States - Research SiteNashville, United States - Research SiteNashville, United States And 143 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## References - PubMed 40341124 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40341124/) Related publication - Related resource (trials.arcusbio.com) Source: [trials.arcusbio.com](https://trials.arcusbio.com/study/?id=STAR-221) ### Other registry identifiers (5) - 2023 - jRCT2051220179 - MOH\_2023-04-30\_012590 - 2023-507522-16-00 - CTR20233469 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05568095) ## Related records ### Drugs (7) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Domvanalimab](https://trialight.com/data/asset/domvanalimab-a06209c7-7e05-4bb9-92e2-610f995f4a6b.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Zimberelimab](https://trialight.com/data/asset/zimberelimab-0723178b-0f17-47bf-bdaa-1046f372b9d2.md) ### Collaborators (2) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) - Taiho Pharmaceutical Co., Ltd. ### Lead sponsors (1) - [Arcus Biosciences, Inc.](https://trialight.com/data/company/arcus-biosciences-inc-5db51387-2105-4a17-8261-60c8f8ffb028.md) ### Conditions (2) - [Esophageal adenocarcinoma](https://trialight.com/data/condition/esophageal-adenocarcinoma-4bf4a077-18f0-54cb-9a30-b8ea936afe32.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) ### Targets (3) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TIGIT](https://trialight.com/data/target/tigit-3420020b-537a-54b3-8cbf-76103a59da64.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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