Clinical trial · Observational
Immune Checkpoint Inhibitors and Pre-existing Autoimmune Diseases
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
NCT03140137CI-TRIAL-00038266completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Autoimmune Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Checkpoint inhibitor therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Autoimmune disease flare
- timeFrame
- through study completion, an average of 1 year
- description
- Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician
Secondary outcomes (1)
- measure
- Other immune/inflammatory complications
- timeFrame
- through study completion, an average of 1 year
- description
- Development of a new immune/inflammatory condition after the start of the therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.