Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases

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.

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Key information

Conditions

Autoimmune Diseases Advanced Cancer Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'AIX, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Checkpoint inhibitor therapy

Drug

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

Primary outcomes

Autoimmune disease flare

Time frame: 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 outcomes

Other immune/inflammatory complications

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

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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 4, 2017
Registry last updated: Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed