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Monoclonal Antibodies

Immunotherapy + Chemotherapy for Gastrointestinal Cancer (EDGE-Gastric Trial)

Phase 2
Recruiting
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

EDGE-Gastric Trial Summary

This trial will test the safety and effectiveness of two different immunotherapy drugs, either alone or in combination with chemotherapy, for people with esophageal or stomach cancer that has spread and can't be removed with surgery.

Who is the study for?
Adults with advanced cancers of the upper gastrointestinal tract, specifically gastric, GEJ, and esophageal adenocarcinoma that can't be surgically removed or has spread. They should be relatively active (ECOG score 0-1), have a life expectancy of at least 3 months, measurable cancer lesions, good organ function, and provide a tumor sample for testing.Check my eligibility
What is being tested?
The study is testing combinations of new drugs Quemliclustat, Zimberelimab, Domvanalimab with/without standard chemotherapy FOLFOX (Fluorouracil + Leucovorin + Oxaliplatin) in three different groups to see which works best for treating these cancers.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system affecting organs; infusion-related symptoms; fatigue; nausea; low blood counts leading to increased infection risk or bleeding problems. Specific side effects depend on the drug combination received.

EDGE-Gastric Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced stomach or esophagus cancer and am expected to live at least 3 more months.
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I can provide a sample of my cancer for testing.
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I am fully active or have some restrictions but can still care for myself.

EDGE-Gastric Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (AEs)
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary outcome measures
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1
Objective Response Rate (ORR) as measured by PD-L1 Expression Level
+7 more

EDGE-Gastric Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced ParticipantsExperimental Treatment2 Interventions
Domvanalimab and zimberelimab Q3W administered by IV infusion
Group II: B2: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Treatment2 Interventions
Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion
Group III: B1: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Treatment2 Interventions
Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion
Group IV: A4 First Line - Treatment Naïve ParticipantsExperimental Treatment4 Interventions
Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Group V: A3 First Line - Treatment Naïve ParticipantsExperimental Treatment5 Interventions
Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W. After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W
Group VI: A2: First Line - Treatment Naïve ParticipantsExperimental Treatment4 Interventions
Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W
Group VII: A1: First Line - Treatment Naïve ParticipantsExperimental Treatment5 Interventions
Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Zimberelimab
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,706 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,079 Previous Clinical Trials
836,859 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,770 Previous Clinical Trials
8,061,766 Total Patients Enrolled

Media Library

Domvanalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05329766 — Phase 2
Gastrointestinal Cancer Research Study Groups: A3 First Line - Treatment Naïve Participants, A4 First Line - Treatment Naïve Participants, A2: First Line - Treatment Naïve Participants, B1: Second Line or greater Checkpoint Inhibitor Naïve Participants, B2: Second Line or greater Checkpoint Inhibitor Naïve Participants, Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants, A1: First Line - Treatment Naïve Participants
Gastrointestinal Cancer Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT05329766 — Phase 2
Domvanalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329766 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation rate of this research endeavor?

"To proceed with this clinical trial, 120 individuals that satisfy the stated inclusion criteria must be enrolled. Patients can find participating sites in Fairfax, Virginia at the Virginia Cancer Specialists-Fairfax Office and Zangmeister Cancer Center in Columbus, Ohio."

Answered by AI

What safety protocols have been established for Domvanalimab use?

"There is some evidence of Domvanalimab's safety, so it was rated a 2 on our team's scale. Although there are no reports confirming its efficacy yet, the Phase 2 trial provides promising indications for further research."

Answered by AI

Are additional participants being welcomed into this research endeavor?

"According to the latest information posted on clinicaltrials.gov, this medical study is still open for recruitment and was initially published on June 10th 2022 with the last update being made in November 10th 2022."

Answered by AI

Are there many medical facilities carrying out this research in North America?

"Currently, 13 locations are running this clinical trial. These sites are located in Fairfax, Columbus, Nashville as well as 10 other cities; thus it is beneficial to seek out the closest medical centre for minimal travel if you decide to enroll."

Answered by AI
~209 spots leftby Sep 2026