Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-06 @ 2:09 PM
Study NCT ID:
NCT05779592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.'}, {'measure': 'Non-urothelial tract recurrence free survival (NUTRFS)', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with treatment-related adverse events (TRAEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Actual treatment status: dosing frequency', 'timeFrame': 'Up to 4 years'}, {'measure': 'Actual treatment status: treatment duration', 'timeFrame': 'Up to 4 years', 'description': 'The time from the start date of nivolumab administration to the last administration date'}, {'measure': 'Actual treatment status: treatment completion rate', 'timeFrame': 'Up to 4 years', 'description': 'The treatment completion rate will be calculated\\* according to the following formula:\n\nTreatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100'}, {'measure': 'Actual treatment status: reason for discontinuation', 'timeFrame': 'Up to 4 years'}], 'secondaryOutcomes': [{'measure': 'DFS', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.'}, {'measure': 'NUTRFS', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.'}, {'measure': 'Number of participants with AEs', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with TRAEs', 'timeFrame': 'Up to 4 years'}, {'measure': 'Actual treatment status: dosing frequency', 'timeFrame': 'Up to 4 years'}, {'measure': 'Actual treatment status: treatment duration', 'timeFrame': 'Up to 4 years', 'description': 'The time from the start date of nivolumab administration to the last administration date'}, {'measure': 'Actual treatment status: treatment completion rate', 'timeFrame': 'Up to 4 years', 'description': 'The treatment completion rate will be calculated\\* according to the following formula:\n\nTreatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100'}, {'measure': 'Actual treatment status: reason for discontinuation', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of death from any cause'}, {'measure': 'Disease-specific survival (DSS）', 'timeFrame': 'Up to 4 years', 'description': 'The time from the date of nivolumab initiation to the date of death due to the primary disease'}, {'measure': 'Number of participants with immune-mediated adverse events (IMAEs) according to the Common Terminology Criteria for Adverse Events (CTCAEs) version 5.0', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with TRAEs leading to treatment discontinuation', 'timeFrame': 'Up to 4 years'}, {'measure': 'Actual treatment status: treatment continuation rate', 'timeFrame': 'Up to 4 years', 'description': 'Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100'}, {'measure': 'Actual treatment status: dosing intensity', 'timeFrame': 'Up to 4 years', 'description': 'Dose intensity (%)=(Actual dose)/(Total dose planned)×100'}, {'measure': 'Post-recurrence treatment status: The number of participants transitioning to treatment', 'timeFrame': 'Up to 4 years', 'description': 'The proportion of eligible patients who completed and started treatment after recurrence.'}, {'measure': 'The number of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence', 'timeFrame': 'Up to 4 years'}, {'measure': 'The number of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence', 'timeFrame': 'Up to 4 years'}, {'measure': 'The proportion of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence', 'timeFrame': 'Up to 4 years'}, {'measure': 'The proportion of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence', 'timeFrame': 'Up to 4 years'}, {'measure': 'The number of participants in each BOR category (CR/PR/stable disease (SD)/progressive disease (PD)/ not evaluated (NE)) receiving treatment after recurrence', 'timeFrame': 'Up to 4 years'}, {'measure': 'The proportion of eligible participants with evaluable disease', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of treatment', 'timeFrame': 'Up to 4 years', 'description': 'The time from the start date of treatment administration to the last administration date after recurrence.'}, {'measure': 'Time to treatment', 'timeFrame': 'Up to 4 years', 'description': 'The time from the start date of nivolumab to the start date of treatment after recurrence.'}, {'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': 'Up to 4 years', 'description': 'Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment'}, {'measure': 'The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants', 'timeFrame': 'Up to 4 years'}, {'measure': 'The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants', 'timeFrame': 'Up to 4 years'}, {'measure': 'The clinical stage prior to NAC', 'timeFrame': 'Up to 4 years'}, {'measure': 'The pathologic stage at the time of radical resection', 'timeFrame': 'Up to 4 years'}, {'measure': 'Treatment completion rate (%)', 'timeFrame': 'Up to 4 years', 'description': '(Participants who completed treatment)/(All eligible participants)x100'}]}, 'conditionsModule': {'keywords': ['UC', 'Nivolumab', 'UTUC'], 'conditions': ['Muscle-invasive Urothelial Carcinoma']}, '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/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a histologically definitive diagnosis of MIUC at each study site and who must have received nivolumab after radical resection\n* Must present at least once to the study site after nivolumab treatment or must have survival data\n\nExclusion Criteria:\n\n* Participants who underwent only partial resection for MIUC\n* Participants treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or Bacillus Calmette-Guérin therapy from the time of radical resection of MIUC to the start of nivolumab\n* Participants previously treated with immune checkpoint inhibitors prior to nivolumab treatment\n\nOther protocol-specific inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05779592', 'acronym': 'ANNIVERSARY', 'briefTitle': 'A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan', 'orgStudyIdInfo': {'id': 'CA209-6H7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023'}]}, 'contactsLocationsModule': {'locations': [{'city': 'City', 'state': 'State', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}