A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
- 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).
- Acronym
- EDGE-Gastric
- Short title
- A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies
- 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)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-06-01
- First posted
- 2022-04-15
- Registry last updated
- 2026-07-29
- Primary completion date
- 2027-01-01
- Start date
- 2022-06-10
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Arcus Biosciences, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05329766
- ClinicalTrials.gov ID
- NCT05329766
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Number of Participants with Adverse Events (AEs)
Timeframe: Up to 18 months
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to 18 months
Objective Response Rate (ORR) as measured by PD-L1 Expression Level
Timeframe: Up to 18 months
Overall survival (OS)
Timeframe: From date of first dose until the date of death due to any cause (approximately 18 months)
Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1
Timeframe: Up to 18 months
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
Timeframe: Up to 18 months
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
Timeframe: Up to 18 months
Plasma concentration of domvanalimab
Timeframe: Up to 18 months
Plasma concentration of zimberelimab
Timeframe: Up to 18 months
Plasma concentration of quemliclustat
Timeframe: Up to 18 months
Percentage of participants with anti-drug antibodies to domvanalimab
Timeframe: Up to 18 months
Percentage of participants with anti-drug antibodies to zimberelimab
Timeframe: Up to 18 months
- 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.
- 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.
- PubMed 41109921Related publication
- Related resource (trials.arcusbio.com)
- 2024-511917-40-00
- 2021-006291-16