Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03140137

Enrollment

112

Registered

2017-05-04

Start date

2017-01-21

Completion date

2018-01-04

Last updated

2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Autoimmune Diseases

Brief 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.

Interventions

DRUGCheckpoint inhibitor therapy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Autoimmune disease flare	through study completion, an average of 1 year	Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician

Secondary

Measure	Time frame	Description
Other immune/inflammatory complications	through study completion, an average of 1 year	Development of a new immune/inflammatory condition after the start of the therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026