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Analysis of Reporting of Cutaneous Toxicities Associated With Immune Checkpoint Inhibitors

NCT04898751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2214

Last updated 2021-05-24

No results posted yet for this study

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

Conditions

  • Cutaneous Toxicity From ICI Therapy

Interventions

DRUG

Immune checkpoint inhibitor (ICI)

Immune checkpoint inhibitors included were targeting either PD-1, PD-L1 or CTLA-4, and had received FDA approval at the time of study (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).

Sponsors & Collaborators

Principal Investigators

  • Shawn Kwatra, MD · Johns Hopkins University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-01
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898751 on ClinicalTrials.gov