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Biomarkers of Immune-Related Toxicity

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ClinicalTrials.gov Identifier: NCT03409016
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : October 15, 2021
Sponsor:
Collaborator:
Cancer League of Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date January 17, 2018
First Posted Date January 24, 2018
Last Update Posted Date October 15, 2021
Actual Study Start Date February 26, 2018
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 5, 2020)
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: January 17, 2018)
Change in inflammatory/autoimmune markers. [ Time Frame: 6 Months ]
1. 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers of Immune-Related Toxicity
Official Title Identifying Biomarkers of Immune-Related Toxicity in Cancer Patients Treated With Immune Checkpoint Inhibitors; A Pilot Project
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
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.
Condition
  • Cancer
  • Metastatic Cancer
Intervention Other: Blood Testing
Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
Study Groups/Cohorts
  • 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.
    Intervention: 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
    Intervention: Other: Blood Testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 5, 2020)
69
Original Estimated Enrollment
 (submitted: January 17, 2018)
95
Estimated Study Completion Date May 31, 2023
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andrea Glass 720-848-0755 andrea.glass@cuanschutz.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03409016
Other Study ID Numbers 17-1940.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Cancer League of Colorado
Investigators
Principal Investigator: Sarah L Davis, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date October 2021