Study of Single Dose Tremelimumab and Durvalumab to Boost Tumor-Fighting T Cells in Esophageal and Stomach Adenocarcinomas with ARID1A Mutation

What this Trial Is About

Researchers are investigating a proof of principle clinical trial to evaluate the effectiveness of a single dose of dual immune checkpoint inhibitors in increasing the number of T cells within tumors in patients with esophageal, gastroesophageal junction, and gastric adenocarcinomas. This study focuses on patients whose tumors have ARID1A mutations, who have not received prior treatment, whose disease has not spread, and who are willing to undergo biopsy procedures. The trial is an early phase 1 study led by the University of California, Irvine. Participants receive a single intravenous dose of two drugs Tremelimumab at 300 mg and Durvalumab at 1500 mg, both administered on day 1. This treatment aims to assess the impact on intra-tumoral T cells. The study uses a single group design and monitors participants over a period extending up to two years. During the trial, participants undergo evaluations including biopsies before and after treatment to measure the percentage completing treatment and biopsy procedures. Researchers assess changes in intra-tumoral effector T cells and effects on circulating cytokines using a 96-cytokine-discovery assay. Safety is monitored by recording adverse events related to the treatment. The total study duration allows for thorough monitoring of biological responses and treatment completion rates.

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