Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03963518
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2019-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
Sponsor:
Organization:
Raw JSON
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Adverse events (serious and non-serious) were not collected for the purpose of this study.', 'description': 'Adverse events (serious and non-serious) were not collected for the purpose of this study', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'nivolumab monotherapy\n\nnivolumab monotherapy: nivolumab monotherapy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 316, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 175, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'nivolumab plus ipilimumab\n\nnivolumab plus ipilimumab: nivolumab plus ipilimumab', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 315, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 151, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'nivolumab monotherapy\n\nnivolumab monotherapy: nivolumab monotherapy'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'nivolumab plus ipilimumab\n\nnivolumab plus ipilimumab: nivolumab plus ipilimumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '0.67'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '0.70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years after the start of treatment', 'description': 'Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.', 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'nivolumab monotherapy\n\nnivolumab monotherapy: nivolumab monotherapy'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'nivolumab plus ipilimumab\n\nnivolumab plus ipilimumab: nivolumab plus ipilimumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '316'}, {'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '316'}, {'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'nivolumab monotherapy\n\nnivolumab monotherapy: nivolumab monotherapy'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'nivolumab plus ipilimumab\n\nnivolumab plus ipilimumab: nivolumab plus ipilimumab'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '90'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '88'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '631', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-05', 'size': 198415, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-21T05:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 631}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2019-05-23', 'resultsFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-12', 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)', 'timeFrame': '4 years after the start of treatment', 'description': 'Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'trial', 'immune-checkpoint inhibitors', 'meta-analysis'], 'conditions': ['Cancer Treated With Immune-checkpoint Inhibitors']}, 'referencesModule': {'references': [{'pmid': '31014514', 'type': 'BACKGROUND', 'citation': 'Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V. Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review. Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.'}, {'pmid': '34929616', 'type': 'BACKGROUND', 'citation': 'Branchoux S, Sofeu CL, Gaudin AF, Kurt M, Moshyk A, Italiano A, Bellera C, Rondeau V. Time to next treatment or death as a candidate surrogate endpoint for overall survival in advanced melanoma patients treated with immune checkpoint inhibitors: an insight from the phase III CheckMate 067 trial. ESMO Open. 2022 Feb;7(1):100340. doi: 10.1016/j.esmoop.2021.100340. Epub 2021 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'previously untreated advanced melanoma patients included in a recently published clinical trial', 'eligibilityCriteria': 'previously untreated advanced melanoma patients.'}, 'identificationModule': {'nctId': 'NCT03963518', 'acronym': 'SURROGATE-ICI', 'briefTitle': 'Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials', 'orgStudyIdInfo': {'id': 'IB2017-SURROGATE-ICI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'nivolumab monotherapy', 'interventionNames': ['Drug: nivolumab monotherapy']}, {'label': 'Experimental', 'description': 'nivolumab plus ipilimumab', 'interventionNames': ['Drug: nivolumab plus ipilimumab']}], 'interventions': [{'name': 'nivolumab monotherapy', 'type': 'DRUG', 'description': 'nivolumab monotherapy', 'armGroupLabels': ['Control']}, {'name': 'nivolumab plus ipilimumab', 'type': 'DRUG', 'description': 'nivolumab plus ipilimumab', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié, Comprehensive Cancer Center', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Carine A Bellera, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}