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NCT Number: NCT06824363

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

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.

Recruiting

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Key information

Conditions

Solid Tumor, Adult Adenocarcinoma Of Esophagus Esophageal Adenocarcinoma Malignant Solid Tumor Stomach Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Farshid Dayyani, MD, PhD

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tremelimumab

Drug

single dose, 300mg IV, day 1

Durvalumab

Drug

single dose, 1500 mg IV, day 1

Primary outcomes

  1. Percentage of Subjects Completing Study Treatment

    Time frame: 2 Years

    Percentage of Subjects Completing the Study Treatment

  2. Percentage of Subjects Completing Post-Treatment Biopsy

    Time frame: 2 Years

    Percentage of Subjects Completing the Post-Treatment Biopsy

Secondary outcomes

  1. Percent Change in the Proportion of Intra Tumoral Effector T-cells

    Time frame: 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

  2. Assessment of effects on circulating cytokines in a 96-cytokine-discovery assay.

    Time frame: 2 years

    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/

  3. Number of Patients who received one dose of Tremelimumab and Durvalumab with reported Adverse Events

    Time frame: 2 years

    Evaluation of safety and adverse events of patients who received one dose of Tremelimumab and Durvalumab using the CTCAE version 5.0

  4. Comparison of T-Cell Infiltration in Various Tumor Mutations

    Time frame: 2 years

    Comparison of T-Cell Infiltration in ARID1A mutated tomors to ARID1A wile-type tumors.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 13, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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