Cancer, Metastatic Cancer
Conditions
Keywords
Immune Checkpoint Inhibitors, Biomarkers, Immune Related Adverse Event
Brief summary
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
Detailed description
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.
Interventions
OTHERBlood Testing
Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
Sponsors
Cancer League of Colorado
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy. | 30 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory/autoimmune markers. | 6 Months | 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 |
| Change in inflammatory/autoimmune markers | 6 months | To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE |
Countries
United States
Outcome results
None listed