Biomarkers of Immune-Related Toxicity

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03409016
• Collaborator: Cancer League of Colorado (Other)
• Enrollment: 69
• Location: 1
• Anticipated Duration (Months): 63.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Metastatic Cancer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 69 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
• Actual Study Start Date: Feb 26, 2018
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy. [30 Months]

   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

Secondary Outcome Measures

1. Change in inflammatory/autoimmune markers. [6 Months]

   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

2. Change in inflammatory/autoimmune markers [6 months]

   To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Cancer League of Colorado

Investigators

• Principal Investigator: Sarah L Davis, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03409016
• Other Study ID Numbers: 17-1940.cc
• First Posted: Jan 24, 2018
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: Immune Checkpoint Inhibitors; Biomarkers; Immune Related Adverse Event
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Aug 16, 2022