Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT04169503
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17562}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-17', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-11-17', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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)..', 'description': 'description of clinical features of the rechallenged cases'}, {'measure': 'Description of the clinical features of cases experiencing a second 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 the clinical features of cases experiencing a second irAEs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nOur objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with immune checkpoint inhibitors and experiencing irAEs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,\n* consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.\n\nExclusion Criteria:\n\n* Chronology not compatible between the drug and the toxicity.'}, 'identificationModule': {'nctId': 'NCT04169503', 'acronym': '19-916', 'briefTitle': 'Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database', 'orgStudyIdInfo': {'id': 'Pharmaco15-19-07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immune Checkpoint Modulator', 'type': 'DRUG', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Basse Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joachim Alexandre, MD', 'role': 'CONTACT', 'email': 'alexandre-j@chu-caen.fr', 'phone': '+33231064670'}], 'facility': 'Alexandre Joachim', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Joachim Alexandre, MD', 'role': 'CONTACT', 'email': 'alexandre-j@chu-caen.fr', 'phone': '+33231064670'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}