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

Early Phase 1Not Yet RecruitingNCT06824363

University of California, Irvine34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult Malignant Solid Tumor Stomach Adenocarcinoma Esophageal Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Subjects Completing Study Treatment

Percentage of Subjects Completing the Study Treatment

Time frame: 2 Years

Percentage of Subjects Completing Post-Treatment Biopsy

Percentage of Subjects Completing the Post-Treatment Biopsy

Time frame: 2 Years

Secondary Outcomes

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

Time frame: 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/

Time frame: 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

Time frame: 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.

Time frame: 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts