This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy. The study includes a control population of patients receiving standard chemotherapy as a comparator. Patients will undergo blood draws at 4 time-points while on standard of care treatment. There are no study-related medications or interventions beyond blood sampling.
Study Type
OBSERVATIONAL
Enrollment
69
Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
University of Colorado Denver
Aurora, Colorado, United States
Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
Difference in baseline inflammatory/autoimmune marker(s) in patients developing immune-related adverse events on immune checkpoint inhibitor therapy according to CTCAE v 4.0 versus those who do not
Time frame: 30 Months
Change in inflammatory/autoimmune markers.
To evaluate the change in inflammatory/autoimmune markers prior to and at 3 time points on immune checkpoint inhibitor therapy, with comparison to patients treated with standard chemotherapy
Time frame: 6 Months
Change in inflammatory/autoimmune markers
To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE
Time frame: 6 months
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