RECRUITING

Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

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Conditions

Cancercheckpoint inhibitorimmuno-oncologycutaneous adverse events

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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 protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.

Official Title

Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

Quick Facts

Study Start:2020-06-01
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04283539

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, \>18 yo
  4. 4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
  5. 5. Receiving, or prior to starting on, a checkpoint inhibitor
  6. 6. Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
  7. 7. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
  8. 8. Life expectancy ≥ 12 weeks
  1. 1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone \>10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions.
  2. 2. Enrollment in any investigational drug trial with a drug that has not been approved
  3. 3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
  4. 4. Pregnancy
  5. 5. Known blood borne infectious disease
  6. 6. Current or pervious diagnosis of a leukemia or lymphoma
  7. 7. Unable to give consent for study participation
  8. 8. Life expectancy \< 12 weeks
  9. 9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results

Contacts and Locations

Study Contact

Joanne Streib
CONTACT
303-398-1731
streibj@njhealth.org

Study Locations (Sites)

National Jewish Health
Denver, Colorado, 80206
United States
The Melanoma and Skin Cancer Institute
Denver, Colorado, 80206
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: National Jewish Health

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 Date2020-06-01
Study Completion Date2025-02

Study Record Updates

Study Start Date2020-06-01
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • checkpoint inhibitor
  • immuno-oncology
  • cutaneous adverse events

Additional Relevant MeSH Terms

  • Cancer