Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140137
• Other study ID #: CHECKAUTO
• Status: Completed
• Start date: January 21, 2017
• Est. completion date: January 4, 2018

Study information

• Verified date: April 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Autoimmune Diseases

Intervention

Drug:
• Checkpoint inhibitor therapy
Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice

Locations

Country	Name	City	State
France	CH d'AIX	AIX en PROVENCE
France	CHU de DIJON	Dijon
France	CHD Vendée	La Roche-sur-Yon
France	Ch Le Mans	Le Mans
France	CH de MACON	Macon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autoimmune disease flare	Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician	through study completion, an average of 1 year
Secondary	Other immune/inflammatory complications	Development of a new immune/inflammatory condition after the start of the therapy	through study completion, an average of 1 year