Evaluating biomarkers for immune-related side effects in cancer treatment
Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated with Immune Checkpoint Inhibitors; a Pilot Project
University of Colorado, Denver · NCT03409016
This study is trying to find out if certain blood markers can help predict side effects in cancer patients receiving immune checkpoint inhibitors for their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 69 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Drugs / interventions | ipilimumab, nivolumab, pembrolizumab, atezolizumab, bevacizumab, cetuximab, trastuzumab, chemotherapy |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03409016 on ClinicalTrials.gov |
What this trial studies
This observational pilot study focuses on identifying potential biomarkers that predict immune-related adverse events in patients undergoing treatment with immune checkpoint inhibitors for metastatic solid tumors. Participants will be monitored through blood draws at four different time points while receiving either immune checkpoint inhibitors or standard chemotherapy as a control. The study aims to correlate these biomarkers with the occurrence of adverse events, providing insights into patient safety and treatment efficacy. There are no additional interventions beyond the blood sampling involved in this study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic solid tumors starting a new regimen of immune checkpoint inhibitors or standard chemotherapy.
Not a fit: Patients with prior immune checkpoint inhibitor therapy, known autoimmune diseases, or those on chronic immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for immune-related adverse events, leading to safer and more personalized cancer treatment strategies.
How similar studies have performed: While the approach of identifying biomarkers for adverse events is being explored in other studies, this specific focus on immune-related toxicity in the context of checkpoint inhibitors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Denver — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah L Davis, MD — University of Colorado, Denver
- Study coordinator: Rebeca Elizondo
- Email: rebeca.elizondo@cuanschutz.edu
- Phone: 720-848-8832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Metastatic Cancer, Immune Checkpoint Inhibitors, Biomarkers, Immune Related Adverse Event