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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Adenocarcinoma; Solid Tumor, Adult; Malignant Solid Tumor; Stomach Adenocarcinoma
• Intervention / Treatment: Drug: Tremelimumab; Drug: Durvalumab

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Farshid Dayyani, MD, PhD; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tremelimumab and Durvalumab; Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1	Drug: Tremelimumab; single dose, 300mg IV, day 1; Drug: Durvalumab; single dose, 1500 mg IV, day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Completing Study Treatment	Percentage of Subjects Completing the Study Treatment	2 Years
Percentage of Subjects Completing Post-Treatment Biopsy	Percentage of Subjects Completing the Post-Treatment Biopsy	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in the Proportion of Intra Tumoral Effector T-cells	Assessment of Effects on Tumor Microenvironment Composition based on the percent change in the proportion of intra tumoral effector T-cells (CD3/CD8) at 2-6 weeks post single dose of STRIDE regiment compared to that at baseline	2 years
Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events	Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0	2 years
Comparison of T-Cell Infiltration in Various Tumor Mutations	Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors.	2 years
Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.	Assessment of effects on circulating cytokine from whole blood collection at baseline and after receiving Tremelimumab and Durvalumab. Blood samples will be used to perform a 96-cytokine-discovery assay. https://www.evetechnologies.com/product/new-human-cytokine-chemokine-96-plex-discovery-assay-array-hd96/	2 years

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Farshid Dayyani, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma Of Esophagus; Antineoplastic Agents, Immunological; Antineoplastic Agents; durvalumab; tremelimumab
• Other Study ID Numbers: 6069; UCI 23-173 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No