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Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy

NCT04641884 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2020-11-24

No results posted yet for this study

Summary

Immune checkpoint inhibitors (monoclonal antibodies targeting cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD- L1)) have revolutionized the treatment of many cancers. The widespread use of these treatments has triggered a new spectrum of immune related adverse events (irAE). Several cases of bullous pemphigoid (BP) triggered by antiPD-1/PDL-1 therapy have been reported, and their characteristics are currently poorly described in the literature. The investigators sought to collect the French cases of BP triggered by antiPD-1/PDL-1 therapy, and to describe their clinical, biological and histological characteristics.

In this national, retrospective, observational study, investigators included patients treated with antiPD-1/PDL-1 therapy, with a diagnosis of bullous pemphigoid occurring during treatment or up to 12 months after its discontinuation. Diagnosis of BP was made by the dermatologist and was based on the following criteria: compatible clinical presentation, compatible histopathology findings, positive direct immunofluorescence (DIF) studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230.

Conditions

  • Bullous Pemphigoid
  • Immunotherapy
  • Programmed Cell Death Ligand 1

Interventions

OTHER

Not concerned

Not concerned

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
93 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • France

Study Locations

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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 NCT04641884 on ClinicalTrials.gov