Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT03568435
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2018-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival status', 'timeFrame': '6 months'}, {'measure': 'Overall survival status', 'timeFrame': '36 months'}, {'measure': 'Best overall response', 'timeFrame': '6 months'}, {'measure': 'Best overall response', 'timeFrame': '36 months'}, {'measure': 'Progression free survival rate', 'timeFrame': '6 months'}, {'measure': 'Progression free survival rate', 'timeFrame': '36 months'}, {'measure': 'Disease free survival', 'timeFrame': '6 months'}, {'measure': 'Disease free survival', 'timeFrame': '36 months'}, {'measure': 'Objective response rate', 'timeFrame': '6 months'}, {'measure': 'Objective response rate', 'timeFrame': '36 months'}, {'measure': 'Duration of response', 'timeFrame': '6 months'}, {'measure': 'Duration of response', 'timeFrame': '36 months'}, {'measure': 'Incidence of adverse events', 'timeFrame': '36 months'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Distribution of clinical characteristics', 'timeFrame': '36 months'}, {'measure': 'Distribution of socio-demographic characteristics', 'timeFrame': '36 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Cancer', 'Renal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with RCC with distant metastasis treated with nivolumab under real clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient with RCC with distant metastasis treated for the first time with nivolumab\n\nExclusion Criteria:\n\n* Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03568435', 'briefTitle': 'Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review', 'orgStudyIdInfo': {'id': 'CA209-8D3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with metastatic RCC taking nivolumab', 'description': 'Specified dose on specified day', 'interventionNames': ['Other: Non-Interventional']}], 'interventions': [{'name': 'Non-Interventional', 'type': 'OTHER', 'description': 'Non-Interventional', 'armGroupLabels': ['Participants with metastatic RCC taking nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070052', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ono Pharma USA Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}