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OpenTrials
Completed

NCT Number: NCT03140137

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

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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

  1. 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

  1. 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

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.

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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.

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