Trials / Unknown
UnknownNCT04169503
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 17,562 (estimated)
- Sponsor
- University Hospital, Caen · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immune Checkpoint Modulator | identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge. |
Timeline
- Start date
- 2019-10-14
- Primary completion
- 2020-01-01
- Completion
- 2020-02-01
- First posted
- 2019-11-20
- Last updated
- 2019-11-20
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04169503. Inclusion in this directory is not an endorsement.