Biomarkers of Immune-Related Toxicity

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 17, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at how certain biological markers in the body can predict potential side effects from a type of cancer treatment called immune checkpoint inhibitors. These treatments help the immune system fight cancer but can sometimes cause unwanted effects. The study aims to find out if there are specific markers that can help identify which patients might experience these side effects.

To be eligible for this study, participants must be at least 18 years old and have metastatic solid tumor cancer (that means cancer that has spread to other parts of the body) but not lymphoma. They should also be starting a new treatment regimen with drugs like ipilimumab, nivolumab, pembrolizumab, or atezolizumab, which are types of immune therapies, or standard chemotherapy. Participants will need to agree to follow the study's procedures and will be monitored throughout the trial to gather important information about their health and any side effects they may experience. This research is important as it could help doctors better understand how to manage side effects in cancer patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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