Status:
ACTIVE_NOT_RECRUITING
Biomarkers of Immune-Related Toxicity
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Cancer League of Colorado
Conditions:
Cancer
Metastatic Cancer
Eligibility:
All Genders
18-100 years
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 c...
Eligibility Criteria
Inclusion
- Metastatic solid tumor cancer of any primary site, with the exception of lymphoma
- ≥18 years of age
- Life expectancy \>6 months
- 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)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
Exclusion
- Prior immune checkpoint inhibitor therapy with anti-CTLA4, anti-PD1 or anti-PD-L1 targeting agent
- Known autoimmune disease
- Known acute or chronic infection, including viral infections such as Hepatitis B, C, and HIV
- Chronic treatment with immune suppressive medications, including steroids, at the time of study enrollment
- Concomitant treatment with a monoclonal antibody in addition to cytotoxic chemotherapy (i.e. bevacizumab, cetuximab, trastuzumab) (control arm only)
- Known pregnancy or lactation
Key Trial Info
Start Date :
April 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 28 2026
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03409016
Start Date
April 18 2018
End Date
May 28 2026
Last Update
September 5 2025
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045