Clinical trial NCT03409016: Biomarkers of Immune-Related Toxicity
Official title: Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated with Immune Checkpoint Inhibitors; a Pilot Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Metastatic Cancer
Keywords: Immune Checkpoint Inhibitors
Biomarkers
Immune Related Adverse Event
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Cancer League of Colorado
First posted: 2018-01-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These patients will be enrolled only at the University of Colorado Cancer Center in the outpatient clinic setting.

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.

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

Primary outcomes:
measure: Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.
timeFrame: 30 Months
Secondary outcomes:
measure: Change in inflammatory/autoimmune markers.
timeFrame: 6 Months
measure: Change in inflammatory/autoimmune markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah L Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: