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Immunotherapy + Chemotherapy for Gastrointestinal Cancer (EDGE-Gastric Trial)
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.
EDGE-Gastric Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEDGE-Gastric Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EDGE-Gastric Trial Design
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Who is running the clinical trial?
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- I have advanced stomach or esophagus cancer and am expected to live at least 3 more months.I am in Cohort A and my tumor is HER-2 positive.I stopped previous immune therapy due to side effects; I've had anti-TIGIT treatment.I can provide a sample of my cancer for testing.My organs and bone marrow are working well.I do not have active brain cancer that is untreated or worsening.I have not had major surgery or serious injury in the last 28 days.I am fully active or have some restrictions but can still care for myself.
- Group 1: A3 First Line - Treatment Naïve Participants
- Group 2: A4 First Line - Treatment Naïve Participants
- Group 3: A2: First Line - Treatment Naïve Participants
- Group 4: B1: Second Line or greater Checkpoint Inhibitor Naïve Participants
- Group 5: B2: Second Line or greater Checkpoint Inhibitor Naïve Participants
- Group 6: Cohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants
- Group 7: A1: First Line - Treatment Naïve Participants
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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