Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1/PD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases

What this Trial Is About

Researchers are investigating how to predict immune-related side effects in people with cancer receiving immunotherapy, known as immune-related adverse events (irAEs). These side effects occur when the immune system attacks healthy tissues, similar to autoimmune diseases. The study aims to see if substances in the blood called interferons (IFNs) can serve as early warning signs for who might develop these reactions. The research includes 300 cancer patients starting immunotherapy and 40 individuals with autoimmune diseases for comparison. Participants include cancer patients treated with immune checkpoint inhibitors (ICIs) and people with autoimmune diseases such as lupus, Sjögren's syndrome, systemic sclerosis, and inflammatory myopathy. Blood samples will be collected at specific times during their treatment or clinical care to measure different IFN types. The study will compare IFN levels between cancer patients who develop irAEs and those who do not, as well as with the autoimmune disease group, to better understand IFN patterns. During the study, participants will provide small blood samples at planned visits. Researchers will analyze IFN levels to identify patterns linked to irAEs and compare these with autoimmune disease profiles. The main outcome is whether irAEs occur within 48 weeks. The goal is to develop a simple blood test to help identify cancer patients at higher risk of these side effects. The study is observational and follows participants over time, with ongoing monitoring and sample collection.

Interferon Signature in Anti-CTLA-4 and Anti-PD-1/PD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients