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Completed NCT04656873

Immuno-Oncology Database and Bioregistry

Conditions: Malignancy, Immune System Diseases, Autoimmune Diseases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 32
Sponsor: UNC Lineberger Comprehensive Cancer Center

Location: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill Chapel Hill North Carolina

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04656873). StuddyBuddy aggregates publicly available trial information.