IntraTumor T-Cell Boost with Dual Immune Checkpoint Inhibitors in ARID1A-Mutated Esophageal/Gastric Adenocarcinoma
Official title: Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082
Run by University of California, Irvine · NCT06824363 · Data updated 2026-11-12
A first-in-human test of a single-dose combination of tremelimumab and durvalumab in adults with ARID1A-mutated, non-metastatic esophageal, GEJ, or stomach adenocarcinoma to see if it can increase tumor T cells.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | January 2027 |
| Study ends | July 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT06824363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with non-metastatic, locally advanced unresectable ARID1A-mutated esophageal, GEJ, or gastric adenocarcinoma who are treatment-naïve and able to undergo serial biopsies.
✕Probably not a fit
Patients with metastatic disease, prior systemic therapy for this cancer, uncontrolled autoimmune disease, or inability to have repeat biopsies may not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase trial tests a single-dose combination of two immune checkpoint inhibitors to see if it prompts more T cells to enter tumors in ARID1A-mutated, non-metastatic esophageal, GEJ, or gastric adenocarcinoma. Eligible participants are treatment-naïve, require a biopsy, and have tumors that have not spread. The study uses ARID1A mutation status determined by tissue or liquid biopsy and requires tumors to be MSI-stable/pMMR. Enrollment is limited to adults with sufficient performance status and the ability to undergo repeat biopsy. The lead site is the Chao Family Comprehensive Cancer Center at UC Irvine, with UC Irvine as sponsor.
Why it matters
Potential benefit: If successful, patients could see an enhanced anti-tumor immune response and potential tumor shrinkage from the dual therapy.
How similar studies have gone: Prior studies using dual checkpoint blockade in solid tumors have shown activity in selected molecular subgroups, but this exact single-dose, ARID1A-mutant gastric/GEJ/esophageal setting is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non metastatic GEC including locally advanced unresectable * Treatment naïve * Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES * MSI-Stable or pMMR * Age ≥ 18 years * Body weight \> 66 pounds * ECOG ≤ 2 * Repeat biopsy feasible * No clinically significant autoimmune disease Exclusion Criteria: * Patients with known metastatic disease * Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma * Patients with uncontrolled autoimmune disease per investigator discretion * Inability or refusal to undergo biopsy procedures to obtain tissue samples
Where it's running
-
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States Recruiting
Study contacts
- Principal investigator: Farshid Dayyani — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.