protocolSection identificationModule nctId: NCT06319820, orgStudyIdInfo id: 42756493BLC3004, secondaryIdInfos id: 2023-507684-19, type: EUDRACT_NUMBER, briefTitle: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer, acronym: MoonRISe-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2028-06-28, completionDateStruct date: 2028-06-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Research & Development, LLC, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC., conditionsModule conditions: Non-Muscle Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 540, type: ESTIMATED, armsInterventionsModule interventions name: TAR-210, interventions name: Gemcitabine, interventions name: MMC, outcomesModule primaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Time to next Treatment (TTNT), secondaryOutcomes measure: High Grade Recurrence-free Survival (HG RFS), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment, secondaryOutcomes measure: Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores, secondaryOutcomes measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores, secondaryOutcomes measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores, secondaryOutcomes measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arkansas Urology, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Genesis Research LLC, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Genesis Research LLC, status: RECRUITING, city: Sherman Oaks, state: California, zip: 91411, country: United States, geoPoint lat: 34.15112, lon: -118.44925, locations facility: MidLantic Urology, status: RECRUITING, city: Bala-Cynwyd, state: Pennsylvania, zip: 19004, country: United States, geoPoint lat: 40.00761, lon: -75.23407, locations facility: Urology Associates, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37209, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Urology Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78745, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Hadassah University Hospita - Ein Kerem, status: RECRUITING, city: Jerusalem, zip: 9112001, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False