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CompletedNCT03140137Updated Apr 22, 2019

Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

An observational study in Autoimmune Diseases and Advanced Cancer, sponsored by University Hospital, Brest. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
112
Ages
18 Years and older
Sex
All
01

Study summary

The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

02

Conditions studied

  • Autoimmune Diseases
  • Advanced Cancer

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03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's enrollment of 112 is below the median of 300 across 208 observational studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a pre-existing autoimmune disease who received immune checkpoint inhibitors for the treatment of an advanced cancer in clinical practice.

Inclusion criteria

  • Pre-existing autoimmune disease as diagnosed by the physician
  • Immune checkpoint inhibitor therapy for an advanced cancer

Exclusion criteria

Exclusion Criteria:

  • Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
  • Absence of follow-up
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
112 participants (actual)
Patient registry
No

Interventions

  • DrugCheckpoint inhibitor therapy

    Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice

06

What researchers measure

Primary outcomes

  1. Autoimmune disease flare

    Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Other immune/inflammatory complications

    Development of a new immune/inflammatory condition after the start of the therapy

    Time frame: through study completion, an average of 1 year

07

Study locations

5 sites
  • CH d'AIX
    AIX en PROVENCE, 13616, France
  • CHU de DIJON
    Dijon, 21079, France
  • CHD Vendée
    La Roche-sur-Yon, 85925, France
  • Ch Le Mans
    Le Mans, 72000, France
  • CH de MACON
    Macon, 78018, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03140137
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
May 4, 2017
Start date
Jan 21, 2017
Primary completion
Jan 4, 2018
Completion
Jan 4, 2018
Last update
Apr 22, 2019

Study contacts

Divi CORNEC
study director · CHRU de Brest

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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