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Immune Checkpoint Inhibitors

Pembrolizumab

Nivolumab

Atezolizumab

Ipilimumab

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.

An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol

Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.

Blood Testing

Andrea Glass

Mark Morrow

Sarah L Davis, MD

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.

Biomarkers of Immune-Related Toxicity

Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project

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

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

To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biomarkers of Immune-Related Toxicity	NCT03409016	Cancer Metastatic Canc...	Blood Testing	18 Years - 100 Years	University of Colorado, Denver
Biomarkers of Immune-Related Toxicity	NCT03409016	Cancer Metastatic Canc...	Blood Testing	18 Years - 100 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for blood testing