An observational study in Cancer and Metastatic Cancer, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Colorado, Denver · Observational
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.
These patients will be enrolled only at the University of Colorado Cancer Center in the outpatient clinic setting.
Exclusion Criteria:
Patients starting treatment with ipilimumab, nivolumab, pembrolizumab, or atezolizumab, alone or in combination, for treatment of a metastatic solid tumor cancer will be enrolled. Patients will receive checkpoint inhibitor therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
Other: Blood Testing
An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol
Other: Blood Testing
Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver