> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-safety-and-efficacy-study-of-treatment-combinations-with-3f4b398e-ad9f-4d15-84a8-5055bc61e278 > Record changed: 2026-10-13 # A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies NCT05329766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Participants 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Lead sponsor Arcus Biosciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Start date 2022-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) Number of sites 43 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Title and summary **Summary** The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Acronym** EDGE-Gastric Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Short title** A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Official title** A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **First posted** 2022-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Primary completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Start date** 2022-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Size and sites **Actual participants** 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Participants** 332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Number of sites** 43 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Lead sponsor** Arcus Biosciences, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Identifiers **Registry ID** NCT05329766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **ClinicalTrials.gov ID** NCT05329766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AEs) Timeframe: Up to 18 months 2. Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Timeframe: Up to 18 months ### Secondary outcomes 1. Objective Response Rate (ORR) as measured by PD-L1 Expression Level Timeframe: Up to 18 months 2. Overall survival (OS) Timeframe: From date of first dose until the date of death due to any cause (approximately 18 months) 3. Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 Timeframe: Up to 18 months 4. Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks Timeframe: Up to 18 months 5. Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 Timeframe: Up to 18 months 6. Plasma concentration of domvanalimab Timeframe: Up to 18 months 7. Plasma concentration of zimberelimab Timeframe: Up to 18 months 8. Plasma concentration of quemliclustat Timeframe: Up to 18 months 9. Percentage of participants with anti-drug antibodies to domvanalimab Timeframe: Up to 18 months 10. Percentage of participants with anti-drug antibodies to zimberelimab Timeframe: Up to 18 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator - Eastern cooperative oncology group (ECOG) Performance Score of 0-1 - At least one measurable target lesion per RECIST v1.1. - Adequate organ and marrow function - Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing Key Exclusion Criteria: - Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous - Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor - Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment. - Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody. - History of trauma or major surgery within 28 days prior to enrollment. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Sites - Research SitePhoenix, United States - Research SiteLos Angeles, United States - Research SiteSanta Monica, United States - Research SiteDerby, United States - Research SiteFort Myers, United States - Research SiteJacksonville, United States - Research SiteSt. Petersburg, United States - Research SiteBoston, United States - Research SiteNew York, United States - Research SiteNew York, United States - Research SiteDurham, United States - Research SiteColumbus, United States - Research SiteOklahoma City, United States - Research SitePortland, United States - Research SiteNashville, United States - Research SiteNashville, United States - Research SiteFairfax, United States - Research SiteToronto, Canada - Research SiteLas Condes, Chile - Research SiteRecoleta, Chile - Research SiteSantiago, Chile - Research SiteTalca, Chile - Research SiteBordeaux, France - Research SiteBrest, France - Research SiteCaen, France And 18 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## References - PubMed 41109921 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41109921/) Related publication - Related resource (trials.arcusbio.com) Source: [trials.arcusbio.com](https://trials.arcusbio.com/study/?id=ARC-21) ### Other registry identifiers (2) - 2024-511917-40-00 - 2021-006291-16 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05329766) ## Related records ### Drugs (6) - [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) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) - [Quemliclustat](https://trialight.com/data/asset/quemliclustat-bf22144a-7270-4d57-8258-cef1e916a241.md) - [Zimberelimab](https://trialight.com/data/asset/zimberelimab-0723178b-0f17-47bf-bdaa-1046f372b9d2.md) ### Collaborators (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### 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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