Status:
COMPLETED
Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors
Lead Sponsor:
Johns Hopkins University
Conditions:
Cutaneous Toxicity From ICI Therapy
Eligibility:
All Genders
Brief Summary
Immune checkpoint inhibitors (ICIs) are associated with a wide variety of cutaneous immune-related adverse events (cirAEs). These cirAEs are reported to be the most common immune-related adverse event...
Detailed Description
ICIs have revolutionized clinical oncologic care. The ICIs that are currently FDA approved fall into three main categories: those that block the cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-...
Eligibility Criteria
Inclusion
- Treated with either Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).
- Developed an adverse reaction that was submitted to a pharmacovigilance center and was determined to be related to aforementioned immune checkpoint inhibitors.
- Adverse reaction was determined to be within the System Organ Class (SOC) "Skin and subcutaneous disorder".
Exclusion
- Adverse event was determined not to be immune-related (for example, infectious etiology) or was a symptom (e.g., edema).
- Adverse event developed before the administration of ICI.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
2214 Patients enrolled
Trial Details
Trial ID
NCT04898751
Start Date
January 1 2008
End Date
August 31 2020
Last Update
May 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Care Center
Baltimore, Maryland, United States, 21215