ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma W/ARID1a Mu

Early Phase 1

Not yet recruiting

• Conditions: Solid Tumor, Adult; Malignant Solid Tumor; Stomach Adenocarcinoma; Esophageal Adenocarcinoma
• Interventions: Drug: Tremelimumab; Drug: Durvalumab

• Registration Number: NCT06824363
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03
• Primary Completion: 2027-01
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tremelimumab and Durvalumab	Tremelimumab	Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1
Tremelimumab and Durvalumab	Durvalumab	Tremelimumab 300 mg IV, single-dose, day 1 Durvalumab 1500mg IV, single-dose, day 1

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Completing Study Treatment	2 Years	Percentage of Subjects Completing the Study Treatment
Percentage of Subjects Completing Post-Treatment Biopsy	2 Years	Percentage of Subjects Completing the Post-Treatment Biopsy

Secondary Outcome Measures

Name	Time	Method
Percent Change in the Proportion of Intra Tumoral Effector T-cells	2 years	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
Assessment of Effects on Circulating Cytokines	2 years
Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events	2 years	Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0
Comparison of T-Cell Infiltration in Various Tumor Mutations	2 years	Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors.

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine; 🇺🇸 Orange, California, United States