Biomarkers of Immune-Related Toxicity

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03409016
• Other study ID #: 17-1940.cc
• Status: Recruiting
• Start date: February 26, 2018
• Est. completion date: May 31, 2027

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: Andrea Glass
• Phone: 720-848-0755
• Email: andrea.glass[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Cancer League of Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy.	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	30 Months
Secondary	Change in inflammatory/autoimmune markers.	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	6 Months
Secondary	Change in inflammatory/autoimmune markers	To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE	6 months