NCT05153304

Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

A Phase I/II Study of Personalized Immunotherapy in Adults With Upper Gastrointestinal Tract Cancers

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer.

Detailed description

The purpose of this study is to determine if it is possible to make and safely administer a 'personalized' cancer vaccine for people diagnosed with an upper gastrointestinal tract cancer. It is known that cancer has mutations (changes in genetic material) that are specific to an individual person and their tumor. These mutations can cause the tumor cells to produce proteins that are different from the body's normal, healthy cells. The study will use a sample of your tumor to create a vaccine against it, with the idea being that the study vaccine will "teach" the body's immune system to recognize and attack the cancer cells. The study will examine the safety of the study vaccine when given at several time points and will examine your blood for signs that the study vaccine causes the immune system to respond. The personalized cancer vaccine will be given alone or in combination with nivolumab. Nivolumab is a drug that blocks certain proteins on cells that help to keep immune responses in check. In a healthy person, this keeps the immune system from attacking healthy cells and tissues, but cancer cells use these proteins to keep the immune system from killing cancer cells and tumors. When these proteins are blocked, the check on the immune system is removed and immune cells may be able to recognize and kill cancer cells. This personalized cancer vaccine is considered experimental because it is not approved by the US Food \& Drug Administration (FDA) as a treatment for cancer. The combination of nivolumab and the personalized cancer vaccine is experimental and is not FDA approved.

Conditions

• Cancer of Gastrointestinal Tract

Interventions

Type	Name	Description
BIOLOGICAL	personalized vaccine	Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.
DRUG	Nivolumab	3mg/kg nivolumab will be administered intravenous (IV) infusion every 3 weeks for 4 doses. After 4 doses, 480 mg nivolumab will be administered intravenous (IV) infusion every 4 weeks.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2021-12-10
• Last updated: 2024-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study