Identifying ways to reduce skin-related side effects from cancer immunotherapy
Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy
This study is testing how to reduce skin problems caused by cancer immunotherapy in patients with solid tumors by looking at their immune responses and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Jewish Health Academic / other |
| Drugs / interventions | chemotherapy, prednisone, immunotherapy |
| Locations | 3 sites (Denver, Colorado and 2 other locations) |
| Trial ID | NCT04283539 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the immunologic responses of cancer patients experiencing immune-related cutaneous adverse events (ircAEs) while receiving checkpoint inhibitors for cancer treatment. By analyzing these patients, the study seeks to identify unique immunologic endotypes that may be associated with these adverse events. Participants will be monitored for their responses to systemic corticosteroids or biologic therapies as part of their treatment plan. The study will include patients with various solid tumors who have developed significant skin-related side effects from their immunotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with solid tumors who are receiving or about to start checkpoint inhibitor therapy and have experienced grade 2 or higher skin-related adverse events.
Not a fit: Patients who are currently using systemic steroids or are enrolled in other investigational drug trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for skin-related side effects in cancer patients undergoing immunotherapy.
How similar studies have performed: Other studies have explored immunologic responses in cancer therapy, but this specific approach to understanding skin-related adverse events is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, \>18 yo 4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma 5. Receiving, or prior to starting on, a checkpoint inhibitor 6. Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only) 7. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only) 8. Life expectancy ≥ 12 weeks Exclusion Criteria: 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. Enrollment in any investigational drug trial with a drug that has not been approved 3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use 4. Pregnancy 5. Known blood borne infectious disease 6. Current or pervious diagnosis of a leukemia or lymphoma 7. Unable to give consent for study participation 8. Life expectancy \< 12 weeks 9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results
Where this trial is running
Denver, Colorado and 2 other locations
- National Jewish Health — Denver, Colorado, United States (Recruiting)
- The Melanoma and Skin Cancer Institute — Denver, Colorado, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Joanne Streib
- Email: streibj@njhealth.org
- Phone: 303-398-1731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.