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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03140137
Other study ID # CHECKAUTO
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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