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Biomarkers of Immune-Related Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409016
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
Cancer League of Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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
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
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Study Type : Observational
Estimated 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 : February 26, 2018
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Identifying biomarkers predictive of immune-related toxicity associated with immune checkpoint inhibitor therapy. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 6 months ]
    To evaluate the impact of change in these markers on patient reported adverse events using the PRO-CTCAE


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409016


Contacts
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Contact: Andrea Glass 720-848-0755 andrea.glass@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Mark Morrow    720-848-0665    mark.morrow@ucdenver.edu   
Principal Investigator: Sarah L Davis, MD         
Sponsors and Collaborators
University of Colorado, Denver
Cancer League of Colorado
Investigators
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Principal Investigator: Sarah L Davis, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03409016    
Other Study ID Numbers: 17-1940.cc
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes