This study is not yet accepting patients

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

a study on Solid Tumor Stomach Cancer Esophageal Cancer Gastric Adenocarcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Farshid Dayyani (uci)

Description

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.

Official 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

Keywords

Solid Tumor, Adult, Malignant Solid Tumor, Stomach Adenocarcinoma, Esophageal Adenocarcinoma, Adenocarcinoma, Durvalumab, Tremelimumab, Tremelimumab and Durvalumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Farshid Dayyani (uci)
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 105 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06824363
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 34 study participants
Last Updated