Biomarkers of Immune-Related Toxicity

Eligibility Criteria

• 1. Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
• 2. ≥18 years of age
• 3. Life expectancy \>6 months
• 4. Starting new regimen of ipilimumab, nivolumab, pembrolizumab or atezolizumab as a single agent or in combination according to standard of care or through compassionate use granted by the pharmaceutical company (immune checkpoint inhibitor arm only) OR Starting new regimen of standard cytotoxic chemotherapy (control arm only)
• 5. Provision to sign and date the consent form
• 6. Stated willingness to comply with all study procedures and be available for the duration of the study
• 1. Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
• 2. Known autoimmune disease
• 3. Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
• 4. Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
• 5. Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
• 6. Known pregnancy or lactation