Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06319820
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604580', 'term': 'erdafitinib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 641}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS)', 'timeFrame': 'From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)', 'description': 'DFS is measured as the time from randomization to the date of the first documented recurrence of non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Time to next Treatment (TTNT)', 'timeFrame': 'From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)', 'description': 'TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.'}, {'measure': 'High Grade Recurrence-free Survival (HG RFS)', 'timeFrame': 'From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)', 'description': 'HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)', 'description': 'PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.'}, {'measure': 'Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment', 'timeFrame': 'From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)', 'description': 'Rate of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.'}, {'measure': 'Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)', 'timeFrame': 'From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)', 'description': 'An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to the date of death (approximately 4 years and 2 months)', 'description': 'OS is defined as the time from randomization to the date of death from any cause.'}, {'measure': 'European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores', 'timeFrame': 'Baseline, Weeks 6, 12, 24, 36, and 48', 'description': 'EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.'}, {'measure': 'European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores', 'timeFrame': 'Baseline, Weeks 6, 12, 24, 36, and 48', 'description': 'EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.'}, {'measure': 'Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores', 'timeFrame': 'Weeks 6, 12, 24, 36, and 48', 'description': 'EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.'}, {'measure': 'Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores', 'timeFrame': 'Weeks 6, 12, 24, 36, and 48', 'description': 'EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Muscle Invasive Bladder Cancer']}, '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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \\>= 3 cm, iii. Early recurrence (less than \\[\\<\\] 1 year), iv. Frequent recurrence (greater than \\[\\>\\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)\n* Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing\n* Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.\n* Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy\n* Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment\n* Have an Eastern Cooperative Oncology Group performance status of 0 to 2\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs\n* Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy\n* Polyuria with recorded 24-hour urine volumes \\> 4000 milliliters (mL)\n* Current indwelling urinary catheters, however, intermittent catheterization is acceptable\n* Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)'}, 'identificationModule': {'nctId': 'NCT06319820', 'acronym': 'MoonRISe-1', 'briefTitle': 'A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations', 'orgStudyIdInfo': {'id': '42756493BLC3004'}, 'secondaryIdInfos': [{'id': '42756493BLC3004', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: TAR-210', 'description': 'Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.', 'interventionNames': ['Combination Product: TAR-210']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: MMC or Gemcitabine', 'description': "Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.", 'interventionNames': ['Drug: Gemcitabine', 'Drug: MMC']}], 'interventions': [{'name': 'TAR-210', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['JNJ-42756493'], 'description': 'TAR-210 will be administered intravesically.', 'armGroupLabels': ['Group A: TAR-210']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine will be administered intravesically.', 'armGroupLabels': ['Group B: MMC or Gemcitabine']}, {'name': 'MMC', 'type': 'DRUG', 'description': 'MMC will be administered intravesically.', 'armGroupLabels': ['Group B: MMC or Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Genesis Research LLC', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Genesis Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91411', 'city': 'Sherman Oaks', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Genesis Research LLC', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Cancer Center Anschultz Cancer Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Colorado Clinical Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'First Urology', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Wichita Urology Group', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70121-2429', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ochsner Health System', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Chesapeake Urology Research Associates', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Brigham And Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Comprehensive Urology', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Mercy Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Specialty Clinical Research of St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Urology Center, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cancer Institute Of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Integrated Medical Professionals', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Associated Medical Professionals of Ny', 'geoPoint': {'lat': 43.04812, 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'RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medizinische Universitat Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4020', 'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Universitaetsklinikum Salzburg Landeskrankenhaus', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medical University Vienna MUV', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9300', 'city': 'Aalst', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Onze -Lieve-Vrouwziekenhuis', 'geoPoint': 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