Biomarkers of Immune-Related Toxicity

NCT03409016 | Active Not Recruiting DMC

• 1 other identifier: 17-1940.cc
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Metastatic Cancer

Keywords

Immune Checkpoint Inhibitors; Biomarkers; Immune Related Adverse Event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in inflammatory/autoimmune markers.

  6 Months

• Change in inflammatory/autoimmune markers

  6 months

Study Arms (2)

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

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

Interventions

Blood Testing OTHER

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

Control; Immune Checkpoint Inhibitor Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sarah L Davis, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: April 18, 2018
• Primary Completion: May 28, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)