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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

UCI Specialty Area: Cancer
Principal Investigator: Farshid Dayyani
A Study On:
Esophagus
Stomach

Study Description

Researchers have found that sometimes the body’s own immune system may slow down or prevent cancer growth. However, in some cases, the immune system stops working effectively, allowing cancer to grow. Cancer cells can send signals, like PD-L1 and CTLA-4, that block the immune system from attacking them. Tremelimumab and durvalumab, which are called immune checkpoint inhibitors, are designed to block these signals, helping the immune response to once again be able to prevent or slow down cancer growth.

The ARID1A gene is often mutated in certain cancers, including esophageal and gastric cancers, and this mutation is linked to a poor response to standard immunotherapy. Research shows that ARID1A mutations reduce the number of immune cells, like T cells, in the tumor, making it harder for the body to fight the cancer. In animal studies, combining tremelimumab (which blocks CTLA-4) and durvalumab (which blocks PD-L1) helped bring T cells back into the tumor and improved the immune response.

The purpose of this research study is to see if a single dose of two immunotherapy drugs, tremelimumab and durvalumab, can increase the number of cancer-fighting immune T cells inside tumors in patients with esophageal, gastroesophageal junction, and gastric cancers that have an ARID1A gene mutation.

The combination of tremelimumab and durvalumab has received FDA approval for treating unresectable hepatocellular carcinoma, a type of liver cancer. However, the use of these drugs in this study is investigational.

Eligibility

You can participate in this study if you satisfy the following criteria:

At least 18 years of age

Body weight > 66 pounds

Confirmed diagnosis of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ) or the stomach with ARID1A mutation

Participants must be willing to undergo repeat EGD (esophagogastroduodenoscopy) biopsy. An EGD is a procedure that examines your esophagus, stomach and first of the small intestine using an endoscope, a tube with a light and camera. An EGD biopsy is a procedure that takes tissue sample from the esophagus, stomach or duodenum during an EGD.

You cannot participate in this study if you have any of the following criteria:

Previous systemic treatment for esophagus, GEJ or the stomach adenocarcinoma

Have known metastatic (spread of cancer cells from the place where they first formed to another part of the body) disease

Uncontrolled autoimmune disease

Pregnant or nursing

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI