ACTIVE_NOT_RECRUITING

Biomarkers of Immune-Related Toxicity

Conditions

Cancer Metastatic Cancer Immune Checkpoint Inhibitors Biomarkers Immune Related Adverse Event

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2018-04-18

Study Completion:2026-05-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03409016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Principal Investigator

Sarah L Davis, MD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Denver

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Sarah L Davis, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-18

Study Completion Date2026-05-28

Study Record Updates

Study Start Date2018-04-18

Study Completion Date2026-05-28

Terms related to this study

Keywords Provided by Researchers

Immune Checkpoint Inhibitors
Biomarkers
Immune Related Adverse Event

Additional Relevant MeSH Terms

Cancer
Metastatic Cancer