Study

IL-6 and IL-6R Genetic Polymorphisms in Immune-Related Adverse Events Caused by Cancer Immunotherapy

Primary Objective: 1) To assess the relationship of polymorphisms in IL-6 and/or IL-6R genes to the development of irAEs in ICI-treated cancer patients. Secondary Objective: 1) To determine whether polymorphisms in IL-6 and/or IL-6R genes affect the production of IL-6 and sIL-6R by CD4 cells before and after ICI treatment. Exploratory Objectives: 1) To evaluate whether polymorphisms in IL-6 and/or IL-6R genes affect levels of IL-6 and sIL-6R in patient serum after ICI treatment. 2) To determine whether serum levels of IL-6 and sIL-6R following ICI therapy increase risk of IRAE development

Why this Research Matters

This study plans to learn more about side effects in patients taking medications called immune checkpoint inhibitors as part of their usual cancer treatment. This study plans to check the blood of patients taking these types of medications to study why these immune-related events occur. There are three parts to this study: 1. Screening (before the study) 2. On Treatment Assessment (up to 3 months) 3. Follow-Up (up to 6 months) Study Visits While you are taking part in this study, many of the tests and procedures that will be performed are usual care for your disease. Some “research related” procedures are performed just for this study and are identified below. Screening Visit Informed consent (research related) Medical History Review of current medications If the screening assessment shows that you are eligible to participate in the study, you will proceed to the baseline and follow-up visits. Week 1 Day 1 Review of current medications Review of side effects Blood collection for biomarker testing: Blood will be collected prior to infusion (research related ) Specimen Banking (research related ) Week 3 Day 1 Review of current medications Review of side effects Blood collection for biomarker testing: Blood will be collected prior to infusion. research related ) Specimen Banking (research related ) Week 12 Day 1 Review of current medications Review of side effects Blood collection for biomarker testing: Blood will be collected prior to infusion. (research related ) Specimen Banking (research related) Week 24 Review of current medications Review of side effects

Who can Participate

Adult

Inclusion Criteria: Metastatic solid tumor cancer of any primary site, with the exception of lymphoma >18 years of age Life expectancy >6 months Starting new regimen of an anti-CTLA4, anti-PD1, anti-PD-L1, or anti-LAG-3 targeting agent alone or in combination according to standard of care Stated willingness to comply with all study procedures and be available for the duration of the study Exclusion Criteria: Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1, anti-PD-L1, or anti-LAG-3 targeting agent Concomitant treatment with cytotoxic chemotherapy in addition to immune checkpoint inhibitor therapy Current or prior diagnosis of autoimmune disease Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment Known pregnancy or lactation