Immuno-Oncology Database and Bioregistry

Completed

Conditions studied: Malignancy, Immune System Diseases, Autoimmune Diseases

In brief

Immunotherapy, especially immune checkpoint inhibitors (ICIs), are effective in treating many different types of cancers. ICIs fight cancer by driving the immune system into an "activated state" that makes it harder for tumor cells to hide and easier for the immune system to destroy them. In doing this, oncologists risk "over activation" where immune cells can cause side effects that could affect any part of the body. These are known as immune related adverse events (irAEs). While irAEs are a known risk of ICIs, scientists and doctors do not understand how they develop, who is more likely to get them, and what is the best way to manage them while still getting the anti-tumor effects from ICIs. The aim of this project is to build an infrastructure for researchers to collaborate in clinical, translational, and basic science research focused on understanding and managing immune related adverse events (irAEs). The investigators will collect research data and samples from patients who receive ICI treatment, including when patients might experience immunotherapy side effects, to store for use in future research studies.

Key facts

Study ID

NCT04656873

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

32

Starts

2021-05-20

Expected to finish

2026-06-04

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age at time of enrollment
• Diagnosis of cancer
• Starting initial ICI therapy or re-starting ICI treatment after a 2-year gap (including off-label use) at UNC-CH using any currently FDA approved ICI's.

You may not qualify if…

• Prior ICI treatment within the last 2 years, including FDA approved ICIs and those under investigation (clinical trials).
• Known and untreated BSL-2+ communicable diseases (active/untreated latent TB, HIV, etc.) or other active infections.

Where it is running

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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