Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors

Completed

Conditions studied: Cutaneous Toxicity From ICI Therapy

In brief

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 events (irAEs) and the first to appear. This study examines the appearance of cirAEs within the World Health Organization (WHO) pharmacovigilance database, VigiBase.

Key facts

Study ID

NCT04898751

Run by

Johns Hopkins University

People needed

2214

Starts

2008-01-01

Expected to finish

2020-08-31

Last updated by the study team

2021-05-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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".

You may not qualify if…

• 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.

Where it is running

• Sidney Kimmel Comprehensive Care Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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