Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641884
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Bullous Pemphigoid Immunotherapy Programmed Cell Death Ligand 1 Other: Not concerned

Detailed Description:
All members of French study Group on Autoimmune Bullous Skin Diseases and French group of Onco-dermatology were asked to report cases of bullous pemphigoid induced by antiPD-1/PDL-1 therapy from 2014 to 2019. In this retrospective, observational cohort study, investigators included patients treated with PD-1 or PD-L1 inhibitor, 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 developed by the French Bullous Study Group : compatible clinical presentation (absence of atrophic scars, absence of mucosal involvement and absence of predominant bullous lesions on the neck and head), compatible histopathology findings (subepidermal blister on skin biopsy; and linear deposits of IgG and C3 along the basement-membrane zone), positive DIF studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230. For each case, collected data were : sex, type of tumor, type of checkpoint inhibitor, age at the onset of the checkpoint inhibitor, time from the onset of BP compared to the onset of the PD-1 inhibitor, clinical presentation of BP, results of complementary exams (skin biopsies, enzyme-linked immunosorbent assay for BP180 and BP230 and indirect immunofluorescence studies if available); treatment of BP used, consequence on antiPD-1/PD-L1 therapy, course of the tumor, other irAEs. Overall tumor response was determined by the treating oncologist and classified using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors).
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical, Biological and Histological Characteristics of Bullous Pemphigoid Induced by antiPD-1/PDL-1 Therapy: A National Retrospective Cohort Study
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Not concerned
    Not concerned

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clinical situation of the patient features [ Time Frame: One day ]
    Composite criteria consisting of the presence of prurit (Yes=0 or No=1). All the measure will give the rate of 0, the abnormal clinical situation

  2. Clinical situation of the patient features [ Time Frame: One day ]
    Composite criteria consisting of the presence of urticarial plaques (Yes=0 or No=1). All the measure will give the rate of 0, the abnormal clinical situation

  3. Clinical situation of the patient features [ Time Frame: One day ]
    Composite criteria consisting of the presence of the number of new blisters per day (less(=1) or more(=0) than 10). All the measure will give the rate of 0, the abnormal clinical situation.

  4. Clinical situation of the patient features [ Time Frame: One day ]
    Composite criteria consisting of eosinophil rate (more than the normal rate = 0 less =1). All the measure will give the rate of 0, the abnormal clinical situation.

  5. Clinical situation of the patient features [ Time Frame: One day ]
    Composite criteria consisting of the enzyme-linked immunosorbent assay for BP180 and BP230 presence =0 absence =1. All the measure will give the rate of 0, the abnormal clinical situation.


Secondary Outcome Measures :
  1. BP treatments [ Time Frame: One day ]
    Rate of corticosteroids, steroids-sparing drugs and other drugs

  2. Cancer evolution [ Time Frame: One day ]
    Rate of relapse remission death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 93 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Already descripted.
Criteria

Inclusion Criteria:

  • Adult patients treated with PD-1 or PD-L1 inhibitor, with a diagnosis of bullous pemphigoid occurring during treatment or up to 12 months after its discontinuation.
  • Diagnosis of the BP based on the following criteria: compatible clinical presentation (absence of atrophic scars, absence of mucosal involvement and absence of predominant bullous lesions on the neck and head), compatible histopathology findings (subepidermal blister on skin biopsy; and linear deposits of IgG and C3 along the basement-membrane zone)
  • Positive direct immunofluorescence studies, positive enzyme-linked immunosorbent assay BP180/enzyme-linked immunosorbent assay BP230.

Exclusion Criteria:

  • Pregnant women
  • BP occurring more than 12 months after antiPD-1/PDL-1 therapy
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641884


Contacts
Layout table for location contacts
Contact: Cécile JUZOT 33253482835 cecile.ju33@hotmail.fr
Contact: Annick COULON 33253482835 bp-prom-regl@chu-nantes.fr

Locations
Layout table for location information
France
University Hospital Recruiting
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04641884    
Other Study ID Numbers: Bullous pemphigoid
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases