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ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma w/ARID1a Mu
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
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.
What is being tested
- Tremelimumab (drug)
- Durvalumab (drug)
Sponsor: University of California, Irvine · Participants: 34 · Started: May 25, 2026
Contact the study team
- Chao Family Comprehensive Cancer Center University of California, Irvine · Phone: 1-877-827-8839
Official record on ClinicalTrials.gov — NCT06824363
Locations in the U.S.
| California | Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.