Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

Completed

• Conditions: Autoimmune Diseases; Advanced Cancer

• Registration Number: NCT03140137
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-21
• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2018-01-04
• Study Completion: 2018-01-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

CH d'AIX; 🇫🇷 AIX en PROVENCE, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CHU de DIJON; 🇫🇷 Dijon, France

CH de MACON; 🇫🇷 Macon, France

Ch Le Mans; 🇫🇷 Le Mans, France