Clinical trial · Observational
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
- 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)
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE. Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Checkpoint Modulator | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of occurrence of second immune-related adverse events (irAEs)
- timeFrame
- Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
- description
- percentage of cases experiencing a second irAE among the rechallenged cases
Secondary outcomes (3)
- measure
- Description of cases experiencing an initial irAEs
- timeFrame
- Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
- description
- description of clinical features of cases experiencing an initial irAEs
- measure
- Description of the rechallenge cases
- timeFrame
- Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction, * consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor. Exclusion Criteria: * Chronology not compatible between the drug and the toxicity.
References
Publications (0)
Data not yet available