Biomarkers of Immune-Related Toxicity

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Metastatic Cancer
• Intervention / Treatment: Other: Blood Testing

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.

• Study Type: Observational
• Enrollment (Estimated): 69

Contacts and Locations

• Study Contact: Name: Andrea Glass; Phone Number: 720-848-0755; Email: andrea.glass@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver
      • Contact: Mark Morrow; Phone Number: 720-848-0665; Email: mark.morrow@ucdenver.edu
      • Principal Investigator: Sarah L Davis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immune Checkpoint Inhibitor Therapy; Patients starting treatment with ipilimumab, nivolumab, pembrolizumab, or atezolizumab, alone or in combination, for treatment of a metastatic solid tumor cancer will be enrolled. Patients will receive checkpoint inhibitor therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.	Other: Blood Testing; Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
Control; An additional 18 patients starting standard chemotherapy will be enrolled as a control population. Patients will receive chemotherapy per standard protocol	Other: Blood Testing; Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Cancer League of Colorado
• Investigators: Principal Investigator: Sarah L Davis, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Immune Checkpoint Inhibitors; Biomarkers; Immune Related Adverse Event
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 17-1940.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No