[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-muscle-invasive-bladder-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-muscle-invasive-bladder-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,65,86,106,129,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580113","phase-2-a-clinical-study-of-intismeran-autogene-v940-and-bcg-in-people-with-bladder-cancer-v940-011interpath-011-100580113",false,"NCT06833073","A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011\u002FINTerpath-011)","A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n\\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization\u002Fallocation and showed BICR-confirmed high-risk NMIBC histology\n\nCohort A:\n\n* Has high-risk non-muscle invasive (HG Ta, T1, and\u002For CIS) UC of the bladder\n* Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG\n\nCohort B:\n\n* Has CIS +\u002F-papillary non-muscle invasive UC of the bladder\n* Is ineligible for, or refusing, any IVESIC therapy\n* Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG\n* Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions\n* Has a known additional malignancy that is progressing or has required active treatment within the last 3 years\n* Has had a myocardial infarction within 6 months of randomization\u002Fallocation\n* Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization\u002Fallocation\n* Has received prior treatment with a cancer vaccine\n* Has immunodeficiency or is receiving chronic systemic steroid therapy\n* Has active autoimmune disease that has required systemic treatment in the last 2 years\n* Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)\n\nCohort A:\n\n* Has current active tuberculosis\n* Has a known history of HIV infection\n\nCohort B:\n\n\\- HIV-infected individuals with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease","ALL","18 Years",{"count":19,"type":20},308,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.\n\nThe standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.\n\nThe goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.",[26,27,28],"Urinary Bladder Neoplasms","Non-Muscle Invasive Bladder Neoplasms","Carcinoma in Situ","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-03-11",{"date":37,"type":20},"2031-09-03",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",89,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100616733","a-study-to-assess-real-world-use-and-outcomes-of-tar-200-for-participants-with-non-muscle-invasive-bladder-cancer-nmibc-in-the-united-states-100616733","NCT07309445","A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States","A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US","Nova-sTAR","Inclusion criteria:\n\n* Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy\n* Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit\u002FStudy visit 1\n* Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice\n* Must provide informed consent as described in the protocol\n\nExclusion criteria:\n\n* Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment\n* Had previous treatment with TAR-200 discontinued prior to baseline visit\u002FStudy visit 1\n* Previously received TAR-200 intravesically as part of a clinical trial(s)\n* Previously received greater than (\\>) 2 doses\u002Fcycles of TAR-200 in the real-world setting\n* Currently participating in an interventional bladder cancer clinical trial",{"count":51,"type":20},150,"OBSERVATIONAL","The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).",[27],"2026-06-04",{"date":57,"type":33},"2026-06-05",{"date":59,"type":20},"2026-06-30",{"date":61,"type":20},"2029-10-09",{"name":63,"class":40},"Janssen Research & Development, LLC",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100586790","phase-3-a-study-to-evaluate-tar-210-versus-intravesical-chemotherapy-treatment-in-participants-with-high-risk-non-muscle-invasive-bladder-cancer-100586790","NCT06919965","A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer","A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)","MoonRISe-3","Inclusion criteria:\n\n* Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded\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* All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy\u002FTURBT, muscularis propria must be present to rule out MIBC\n* Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta\u002Fany T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta\u002Fany T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \\>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2\n* Must be ineligible for or refusing radical cystectomy (RC)\n\nExclusion criteria:\n\n* Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \\[i.e.\\], T2, T3, T4, N+, and\u002For M+)\n* Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\\[N0, M0\\] with a Gleason score less than or equal to \\[\\\u003C=\\] 7a, treated locally only \\[radical prostatectomy\u002Fradiation therapy\u002Ffocal treatment\\]) and other malignancy that is considered at minimal risk of recurrence\n* Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210\n* A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\\>) 4,000 milliliters (mL)\n* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable",{"count":74,"type":20},220,[76],"PHASE3","The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).",[27],{"date":57,"type":33},{"date":81,"type":33},"2025-09-10",{"date":83,"type":20},"2032-03-16",{"name":63,"class":40},109,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100540667","phase-3-a-study-to-evaluate-tar-210-versus-single-agent-intravesical-cancer-treatment-in-participants-with-bladder-cancer-100540667","NCT06319820","A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer","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","MoonRISe-1","Inclusion Criteria:\n\n* Main study only: 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)\u002F Grade 1 (G1): primary or recurrent, b. Ta LG\u002FG2: 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 \\[\\\u003C\\] 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* Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG\u002FG1, b. Ta LG\u002FG2, and \\>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \\>=3 cm\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\u002Fprogression) 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\u002For not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)\n\nSubstudy:\n\n\\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis",{"count":95,"type":20},641,[76],"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.",[27],{"date":57,"type":33},{"date":101,"type":33},"2024-04-18",{"date":103,"type":20},"2032-12-31",{"name":63,"class":40},193,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100463550","phase-1-study-of-erdafitinib-intravesical-delivery-system-for-localized-bladder-cancer-100463550","NCT05316155","Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer","Phase 1\u002F2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\nParts 1-3:\n\n* Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder\n* For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests\n* Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible\n* Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)\n* Cohorts 2 and 4: Willing and eligible for RC\n\nPart 4:\n\n* Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors\n* Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size\n* Must submit tissue and urine for FGFR testing\n* Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment\n\nExclusion Criteria:\n\nParts 1-3:\n\n* Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium\n* Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor\n* Received pelvic radiotherapy \\\u003C=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (\\>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis\n* Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system\n* Indwelling urinary catheter. Intermittent catheterization is acceptable\n\nPart 4:\n\n* Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG\u002FG2 or HG\u002FG3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (\\>=5) years ago and there is documentation of low grade (LG) Ta thereafter\n* Known allergies, hypersensitivity, or intolerance to any study component or its excipients\n* Has a current diagnosis of newly diagnosed IR-NMIBC\n* Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent\u002Ftherapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study\n* Evidence of current bladder perforation by cystoscopy or imaging",{"count":114,"type":20},235,[116,23],"PHASE1","The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\\[s\\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).",[27],[120,121],"Non-Muscle Invasive Bladder Cancer (NMIBC)","Muscle Invasive Bladder Cancer (MIBC)",{"date":57,"type":33},{"date":124,"type":33},"2022-04-11",{"date":126,"type":20},"2029-07-24",{"name":63,"class":40},59,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":146,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100476433","phase-1-a-phase-1-open-label-trial-of-belzupacap-sarotalocan-au-011-in-bladder-cancer-100476433","NCT05483868","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer","A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer","Inclusion Criteria:\n\n1. Meet the following histopathologic requirements for urothelial carcinoma:\n\n   * For Cohorts 1b, 4a-c:\n\n   histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).\n\n   For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to\n\n   AUA risk classification guidelines) is required, specifically:\n   * Multifocal LG Ta; OR\n   * Solitary LG Ta \\>3 cm; OR\n   * Low-grade Ta with prior recurrence(s) within 1 year.\n\n   For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:\n   * Ta HG papillary disease with or without CIS; OR\n   * T1 papillary disease with or without CIS\n   * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)\n   * BCG-refractory participants are excluded. BCG-refractory is defined by the following:\n\n     * Persistent HG disease at 6 months following adequate BCG (defined as ≥5\u002F6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR\n     * HG T1 disease at first evaluation (3 months) after BCG, OR\n     * Persistent CIS that remains despite a second BCG course, OR\n     * Disease progression in stage or grade during BCG therapy, including maintenance\n2. Have no evidence of current or prior metastatic urothelial carcinoma\n3. Adequate bone marrow, renal, and hepatic function\n\nExclusion Criteria:\n\n1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.\n2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.\n3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.\n4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.\n5. Chronic active hepatitis B or C and HIV.",{"count":137,"type":20},55,[116],"The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.",[141,142,143,27,144,145],"Non-muscle-invasive Bladder Cancer","NMIBC","Non-Muscle Invasive Bladder Carcinoma","Non-Muscle Invasive Bladder Urothelial Carcinoma","Urothelial Carcinoma Bladder",[142,147,148,149,150,151,152,153,154],"TURBT","Intramural","Belzupacap Sarotalocan","Intratumoral","urothelial","bladder cancer","bel-sar","AU-011","2026-04-13",{"date":157,"type":33},"2026-04-15",{"date":159,"type":33},"2022-09-26",{"date":161,"type":20},"2027-03",{"name":163,"class":40},"Aura Biosciences",17,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":174,"conditions":175,"keywords":185,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":64},"100528944","study-on-the-occurrence-of-possible-relapses-and-on-the-quality-of-life-in-patients-who-underwent-turbk-100528944","NCT06167356","Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.","Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Endoscopic Resection Surgery for Bladder Cancer (TURBK).","Inclusion Criteria:\n\n* 18 years or older\n* Patients with non-muscle invasive bladder cancer\n* Indication to cancer removal through endoscopic resection surgery\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to read and sign the informed consent",{"count":173,"type":20},20000,"A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.",[176,27,144,177,178,179,180,181,182,183,184],"Non Muscle Invasive Bladder Cancer","Bladder Cancer","Bladder Disease","Bladder Neoplasm","Bladder Urothelial Carcinoma","Bladder Cancer Stage I, With Cancer in Situ","Bladder Cancer Recurrent","Bladder Urothelial Carcinoma in Situ","Bladder Urothelial Dysplasia",[186,180,179,178,177,187],"Intravescical Therapies","Intravesical Instillations","2023-12-11",{"date":190,"type":33},"2023-12-12",{"date":192,"type":33},"2013-11-27",{"date":194,"type":20},"2063-11-27",{"name":196,"class":197},"IRCCS San Raffaele","OTHER"]