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Tremelimumab and Durvalumab for Gastro-Esophageal Adenocarcinoma with ARID1A Mutation

This study is looking at a single dose of two immune checkpoint inhibitor drugs, Tremelimumab and Durvalumab, for people with stomach or esophageal adenocarcinoma (a type of cancer). You might be able to join if your cancer has not spread, you haven't had treatment for it yet, and your tumor has a specific change called an ARID1A mutation. The researchers want to see if these drugs can increase certain immune cells (T cells) within the tumor. The main goals are to see how many people complete the treatment and how many have a follow-up biopsy, both measured over two years.

Study design
This is a proof-of-principle study planning to enroll 34 adult participants. The study is testing a single dose of two drugs.
What's involved
You would receive a single dose of Tremelimumab and Durvalumab. You would also need to be willing to have repeat biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to measure completion of treatment and post-treatment biopsy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06824363

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~34 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:TremelimumabDurvalumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Subjects Completing Study Treatment
Measured over 2 Years
+1 more outcome measured

Conditions

Solid Tumor, Adult
Malignant Solid Tumor
Stomach Adenocarcinoma
Esophageal Adenocarcinoma

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Where it's being run

1 sites across 1 states
California1

Study leadership

  • Farshid Dayyani · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Subjects Completing Study Treatment2 Years

    Percentage of Subjects Completing the Study Treatment

  • Percentage of Subjects Completing Post-Treatment Biopsy2 Years

    Percentage of Subjects Completing the Post-Treatment Biopsy