[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-muscle-invasive-bladder-cancer":115},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,44,0,25,[9,48,77,102,131,153,184,212,236,268,291,320,343,369,398,419,450,472,501,521,545,572,595,621,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100512340","phase-2-safety-and-efficacy-study-of-intravesical-instillation-of-tara-002-in-adults-with-high-grade-non-muscle-invasive-bladder-cancer-100512340",false,"NCT05951179","Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer","A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults With High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-2","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis (Cohort A). Participants with CIS (± Ta\u002FT1) who are BCG unresponsive.\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor","ALL","18 Years",{"count":21,"type":22},131,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta\u002FT1).\n\nThe purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and efficacy of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a).\n\nThis Phase 2 study includes participants with CIS NMIBC (± Ta\u002FT1) with active disease, defined as disease present at last tumor evaluation (within 3 months) prior to signing the ICF.\n\nParticipants will be enrolled into one of 2 cohorts:\n\nCohort A:\n\n* Participants with CIS (± Ta\u002FT1) who are BCG naive, or\n* Participants with CIS (± Ta\u002FT1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis\n\nCohort B:\n\n* Participants who are BCG unresponsive",[28],"Non-muscle Invasive Bladder Cancer",[30,31,32,33,34],"Non-muscle invasive bladder Cancer","bladder cancer","high grade Ta","high grade NMIBC","carcinoma in situ","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2023-09-15",{"date":43,"type":22},"2032-03",{"name":45,"class":46},"Protara Therapeutics","INDUSTRY",71,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100565072","phase-1-a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-patients-with-bladder-cancer-mk-2870-027-100565072","NCT06637423","A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)","A Phase 1\u002F2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)","TroFuse-027","Inclusion Criteria:\n\nThe key inclusion criteria include but are not limited to the following:\n\n* Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder\n* Must have visible tumor by cystoscopy within 12 weeks prior to first dose\n* Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:\n\n  * Multiple tumors\n  * \\>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening\n  * Early recurrence (\\\u003C1 year) of the initial diagnosis of low-grade disease\n  * Solitary tumor \\>3 cm\n  * Failure of prior intravesical treatment\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose\n\nExclusion Criteria:\n\nThe key exclusion criteria include but are not limited to the following:\n\n* Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder\n* Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)\n* Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and\u002For blepharitis, or severe corneal disease that prevents and\u002For delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.",{"count":57,"type":22},32,[59,25],"PHASE1","The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.",[62],"Non-Muscle Invasive Bladder Cancer",[62,64,65,66],"Low Grade","Intermediate Risk","Recurrent Low-Grade","2026-06-11",{"date":69,"type":39},"2026-06-12",{"date":71,"type":39},"2024-12-20",{"date":73,"type":22},"2028-07-31",{"name":75,"class":46},"Merck Sharp & Dohme LLC",13,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100604038","exploration-of-novel-ai-enabled-blue-light-enhanced-cystoscopy-100604038","NCT07144319","Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy","ENAiBLE","Inclusion Criteria:\n\n* Age 18 or older\n* Written informed consent, approved by relevant IRB\u002FIEC, signed\n* Hexvix\u002FCysview has been prescribed in the usual manner in accordance with the terms of the marketing authorization (see Appendix B)\n* Physician has planned to do a blue light cystoscopy on the patient and to obtain biopsies, if clinically indicated, of suspicious lesions with video confirmation.\n* Patient has not previously taken part in this study\n\nExclusion Criteria:\n\n* None",{"count":85,"type":22},500,"OBSERVATIONAL","Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions. Unlike regular white light cystoscopy, blue light cystoscopy makes use of a drug that induces fluorescence under blue light preferentially in neoplastic and malignant cells that helps visualize bladder lesions during the cystoscopic procedure. Blue light cystoscopy has shown to improve detection of bladder cancer.\n\nCystoscopy, including blue light cystoscopy, is a procedure involving assessment of the visual appearance of the bladder surface, leading to decisions of taking biopsies, remove suspicious areas and assign treatment options. The assessment is subjective and has a large operator variability. These shortcomings show an opportunity for computer aided detection (CADe) medical device to add value to both clinicians and patients.\n\nThe objective of this data collection study is to build a high-quality, diverse data set of video, image recordings and relevant clinical data from BLC procedures performed as part of routine clinical practice to train a computer-aided detection (CADe) algorithm for real- time lesion detection during cystoscopy. The data will be used to support the training, non-clinical technical development and testing of such AI algorithms for use during cystoscopy and to provide documentation needed for training of such algorithms and to assist in guiding future validation of such algorithms.\n\nExploratory purposes of the study is to use data to explore future AI algorithms in bladder cancer, such as computer-aided diagnosis (CADx) AI algorithms, image enhancement and cystoscopy improvement algorithms, including bladder mapping, tumor visualization, cystoscopy documentation, and combination models of image and clinical data including risk assessment, clinical outcomes, and disease modeling",[89,28],"Bladder Cancer",[31,91,92],"artificial intelligence","cystoscopy","2026-06-09",{"date":67,"type":39},{"date":96,"type":39},"2026-03-25",{"date":98,"type":22},"2027-12",{"name":100,"class":46},"Photocure",4,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":101},"100638648","phase-2-is-prolonged-systemic-immunotherapy-necessary-after-achieving-tumor-free-status-in-patients-with-extensive-transurethrally-unresectable-very-high-risk-nmibc-100638648","NCT07625527","Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?","Randomized Trial of Active Surveillance Versus Continued Systemic Immunotherapy After Achieving Tumor-Free Status in Extensive Transurethrally Unresectable Very-High-Risk NMIBC","Inclusion Criteria\n\n* Has histologically confirmed very-high-risk non-muscle-invasive urothelial carcinoma of the bladder.\n* Has transurethrally unresectable bladder tumor, defined as visually incomplete TURBT and\u002For extensive high-volume disease considered unsuitable for complete and oncologically adequate transurethral resection.\n* Has undergone cystoscopy and TURBT evaluation before study enrollment.\n* Has received systemic PD-1\u002FPD-L1 inhibitor-based bladder-sparing therapy before randomization.\n* Has achieved tumor-free status before randomization, defined as:\n\n  1. No visible bladder tumor on cystoscopy;\n  2. Negative bladder biopsy and\u002For TURBT pathology;\n  3. Negative urine cytology;\n  4. Negative urinary tumor DNA (utDNA);\n  5. No radiographic evidence of progression or metastasis.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Has adequate organ function.\n* Has provided written informed consent.\n\nCohort A Only\n\n* Achieved tumor-free status at the initial response evaluation after induction systemic therapy.\n* Maintained tumor-free status after additional systemic therapy before randomization.\n\nCohort B Only\n\n* Did not achieve tumor-free status at the initial response evaluation because of residual non-muscle-invasive disease.\n* Subsequently underwent complete TURBT\u002Fresection of residual disease followed by additional systemic therapy.\n* Achieved tumor-free status at the second response evaluation before randomization.\n\nExclusion Criteria\n\n* Has muscle-invasive bladder cancer (≥T2), locally advanced unresectable disease, nodal disease, or distant metastasis.\n* Has concurrent upper tract urothelial carcinoma.\n* Has persistent visible tumor, positive bladder pathology, positive urine cytology, or positive utDNA before randomization.\n* Has received prior systemic immunotherapy for metastatic urothelial carcinoma.\n* Has active autoimmune disease requiring systemic treatment.\n* Is receiving systemic immunosuppressive therapy.\n* Has uncontrolled infection requiring systemic therapy.\n* Has another active malignancy requiring systemic treatment.\n* Has known active hepatitis B, hepatitis C, human immunodeficiency virus infection, or active tuberculosis.\n* Has pregnancy or breastfeeding.\n* Has any medical or psychiatric condition that, in the investigator's judgment, would interfere with study participation or interpretation of results.",{"count":110,"type":22},120,[25],"Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with transurethral resection of bladder tumor (TURBT). However, the optimal duration of systemic immunotherapy after achieving a tumor-free status remains uncertain. Prolonged treatment may increase toxicity, treatment burden, and cost, while some patients may maintain durable disease control without continued therapy.\n\nThis randomized study aims to evaluate whether active surveillance after achieving tumor-free status is a feasible alternative to continued systemic immunotherapy in patients with extensive transurethrally unresectable very-high-risk NMIBC.\n\nPatients will initially receive systemic immunotherapy-based treatment followed by disease evaluation using cystoscopy with biopsy and\u002For TURBT, urine cytology, urinary tumor DNA (utDNA), and imaging assessments. Patients who achieve tumor-free status after treatment and complete resection of visible disease will be randomized to either active surveillance or continued systemic immunotherapy.\n\nThe study will evaluate recurrence outcomes, bladder preservation, progression, safety, and patient management strategies following achievement of tumor-free status. The trial also aims to explore the role of urinary tumor DNA in identifying patients who may safely undergo treatment de-escalation and active surveillance.",[114,115],"Bladder (Urothelial, Transitional Cell) Cancer","Non Muscle Invasive Bladder Cancer",[117,118,119],"Non-muscle-invasive bladder cancer (NMIBC)","Liquid biopsy","Immunotherapy","NOT_YET_RECRUITING","2026-05-28",{"date":123,"type":39},"2026-06-04",{"date":125,"type":22},"2026-05-30",{"date":127,"type":22},"2032-05-30",{"name":129,"class":130},"Tianjin Medical University Second Hospital","OTHER",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100590837","phase-2-intravesical-chemotherapy-in-combination-with-systemic-pembrolizumab-in-nmibc-unresponsive-or-exposed-to-bcg-therapy-100590837","NCT06972615","Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy","A Phase II, Single Arm Study, Evaluating Intravesical Gemcitabine\u002FDocetaxel in Combination With Systemic Pembrolizumab in Subjects With High Risk NMIBC Unresponsive or Exposed to Bacillus Calmet-Guerin (BCG) Therapy","Inclusion Criteria:\n\n1. Be willing and able to provide documented informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n2. Be ≥18 years of age on the day of signing informed consent.\n3. Have a histologically confirmed diagnosis of high-risk non-muscle invasive (T1, High Grade Ta and\u002For CIS) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional\u002Fnon-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology. Subjects with predominant or exclusively non-transitional cell histology are not allowed. Confirmation of histology, grade and stage will be performed by central review and must be completed during the screening period and prior to enrollment.\n4. In subjects who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:Attainment of a visually complete resection of all papillary tumors (Ta and T1) 5- Have been treated with adequate BCG therapy and have developed high risk NMIBC that is unresponsive or exposed to BCG therapy.\n\nAdequate BCG therapy must include:\n\n* An induction course with at least 5 out of 6 BCG instillations (adequate induction); and\n* At least 7 out of 9 BCG instillations within 9 months of the first instillation of adequate induction therapy\n\nBCG unresponsive high risk NMIBC is defined as:\n\n* Stage progression at 3 months (±4 weeks) despite adequate induction therapy (e.g., Ta to T1, or CIS to T1; note: adequate induction therapy only, defined above, is required in this case); or\n* High grade T1 disease at the first evaluation after adequate BCG induction or\n* Persistent high risk NMIBC at 6 months (±4 weeks) after adequate BCG; or\n* Recurrent high risk NMIBC within 12 months of the last BCG instillation despite having received adequate BCG.\n\nBCG Exposed is defined as: having high-grade persistent (BCG resistant) or recurrent NMIBC within 24 months of the last BCG dose but not meeting the definition of BCG-unresponsive\n\nExclusion Criteria:\n\n* 1\\. Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.\n\n  2\\. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle-invasive transitional cell carcinoma of the urothelium.\n\n  3\\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n\n  4\\. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy\u002F transurethral resection of bladder tumor to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy\u002F transurethral resection of bladder tumor, during the screening period, such as with chemotherapy as per local\u002Fregional practices, is acceptable.)\n\n  5\\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent",{"count":139,"type":22},37,[25],"interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC",[115],"2026-05-26",{"date":121,"type":39},{"date":146,"type":39},"2026-05-21",{"date":148,"type":22},"2030-06-15",{"name":150,"class":151},"BLATAM","NETWORK",1,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100493875","phase-1-a-study-of-stm-416-administered-to-patients-undergoing-turbt-for-recurrent-bladder-cancer-100493875","NCT05710848","A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer","A Phase 1\u002F2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer","Inclusion Criteria:\n\n1. Are aged 18 years or older;\n2. Have a history of pathologically confirmed high-grade Ta or T1 NMIBC without CIS who have completed SOC previously, with recurrent papillary disease seen on cystoscopy, and who are undergoing TURBT without perioperative intravesical chemotherapy;\n3. Are considered high risk for recurrence;\n4. Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2;\n5. Have adequate organ and marrow function as defined below:\n\n   * Hemoglobin 9.0 g\u002FdL;\n   * Absolute neutrophil count 1.5 × 109\u002FL (1500 per mm3);\n   * Platelet count 75 × 109\u002FL (75,000 per mm3);\n   * Serum bilirubin 1.5 × institutional upper limit of normal (ULN);\n   * AST (serum glutamic-oxaloacetic transaminase)\u002FALT (serum glutamic-pyruvic transaminase) 2.5 × institutional ULN; and\n   * Creatinine CL 60 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine CL: Males: Creatinine CL (mL\u002Fmin) = Weight (kg) × (140 - Age)\u002F72 × serum creatinine (mg\u002FdL); or Females: Creatinine CL (mL\u002Fmin) = Weight (kg) × (140 - Age) × 0.85\u002F72 × serum creatinine (mg\u002FdL).\n\nExclusion Criteria:\n\n1. Have a history of CIS or MIBC;\n2. Are receiving any other investigational agents;\n3. Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to resiquimod (R848), or excipients used in STM-416 including poloxamer 407 and sodium hyaluronate;\n4. Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n   Urinary tract infections are not exclusionary unless they are NCI-CTCAE Grade 3 or higher;\n5. Are a woman of childbearing potential regardless of contraceptive use; Note: Women of childbearing potential are only to be excluded in Phase 1 and Phase 2a to avoid bias due to the low prevalence of NMIBC in this population. However, they will be included in subsequent Phase 2\u002F3 studies.",{"count":161,"type":22},75,[59,25],"This is a first-in-human (FIH), Phase 1\u002F2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.",[165],"Non-muscle-invasive Bladder Cancer",[167,168,169,170,171,62,172,119,173],"Open-label","Dose escalation","STM-416","Resiquimod","Toll-like receptor 7\u002F8","TURBT","BCG","2026-05-23",{"date":176,"type":39},"2026-05-27",{"date":178,"type":39},"2023-07-11",{"date":180,"type":22},"2026-08",{"name":182,"class":46},"SURGE Therapeutics",20,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":152},"100637474","comparison-of-ct-and-mr-vi-rads-imaging-for-local-bladder-cancer-staging-100637474","NCT07602010","Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging","Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Newly diagnosed bladder cancer on cystoscopy\n* Planned TURBT or cystectomy within 6 weeks\n* Eligible for both CT and MRI within 6 weeks\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Contraindications to MRI or iodinated contrast media\n* Prior treatment for bladder cancer\n* Pregnancy\n* Non-malignant bladder lesions\n* Tumors located in bladder diverticula",{"count":192,"type":22},150,"This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.",[89,195,196,115],"Urothelial Carcinoma (UC)","Muscle Invasive Bladder Cancer (MIBC)",[198,199,200,201,202],"MRI","Computed Tomography","VI-RADS","Local Staging","Diagnostic Accuracy","2026-05-15",{"date":205,"type":39},"2026-05-22",{"date":207,"type":39},"2026-04-22",{"date":209,"type":22},"2028-10-31",{"name":211,"class":130},"Oslo University Hospital",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":219,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100587507","phase-3-a-study-comparing-standard-treatments-in-people-with-non-muscle-invasive-bladder-cancer-nmibc-100587507","NCT06929286","A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)","COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial","Inclusion Criteria:\n\n* 21 years of age or older\n* Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists\n* One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed\n\n  °Any amount of maintenance BCG is allowed\n* In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment\n\n  °An intravesical agent can include BCG or any other NMIBC treatment\n* In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than \"best usual care\"\n\nExclusion Criteria:\n\n* Opting for treatment with radical cystectomy\n* Currently enrolled in a clinical trial of an experimental therapy for NMIBC\n* Prior exposure to nadofaragene firadenovec","21 Years",{"count":221,"type":22},125,[223],"PHASE3","The purpose of this study is to compare the effectiveness of different FDA-approved\u002FNCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).",[62],"2026-05-07",{"date":228,"type":39},"2026-05-11",{"date":230,"type":39},"2025-04-11",{"date":232,"type":22},"2028-04",{"name":234,"class":130},"Memorial Sloan Kettering Cancer Center",9,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":248,"conditions":249,"keywords":253,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":152},"100610763","hyperthermic-intravesical-chemotherapy-hivec-in-bcg-non-responsive-high-grade-nmibc-patients-100610763","NCT07231809","Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients","Hyperthermic Intravesical Chemotherapy (HIVEC) In Patients With BCG-Non Responsive Or Intolerant High-Grade BCG-Infiltrating Non-Muscle-Infiltrating Bladder Cancer And Not Eligible For Radical Cystectomy: Phase II Study (SMG-Bladder 01).","HIVEC","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade non-muscle-invasive bladder cancer (NMIBC), including Ta, T1, and\u002For carcinoma in situ (CIS).\n* BCG-unresponsive or BCG-intolerant disease according to international definitions (persistent or recurrent high-grade NMIBC after adequate BCG therapy).\n* Patient is ineligible for, or refuses, radical cystectomy.\n* Candidate for hyperthermic intravesical chemotherapy (HIVEC) according to clinical judgment.\n* ECOG Performance Status 0-2.\n* Adequate organ function according to institutional standards.\n* Ability and willingness to comply with study procedures and follow-up schedule.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Muscle-invasive bladder cancer (≥ T2) or metastatic disease.\n* Active urinary tract infection at baseline.\n* Previous treatment with HIVEC or other intravesical hyperthermia systems.\n* Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy.\n* Active uncontrolled bleeding or gross hematuria preventing intravesical instillation.\n* Upper urinary tract urothelial carcinoma.\n* Pregnant or breastfeeding women.\n* Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.",{"count":245,"type":22},50,[247],"NA","This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are BCG-non-responsive or BCG-intolerant and are ineligible for, or refuse, radical cystectomy. Mitomycin C is an approved medicinal product used within routine clinical practice and administered with a CE-marked recirculation device (BRS Combat system) that maintains the solution at approximately 43°C for 60 minutes. The treatment schedule consists of 6 weekly induction instillations followed by 9 monthly maintenance instillations.\n\nThe co-primary objectives are to describe the safety and toxicity profile of HIVEC, including treatment discontinuations due to procedure-related toxicity, and to estimate the 12-month recurrence-free survival (12moRFS). Secondary objectives include characterizing patterns of non-muscle-invasive and muscle-invasive recurrences, bladder cancer-specific survival, overall survival, and quality of life. Approximately 50 patients will be enrolled in this single-center pilot study to generate exploratory safety and efficacy data in this high-risk population and to support the design of future randomized trials",[115,89,250,251,252],"Carcinoma in Situ of Bladder","Urinary Bladder Neoplasms","Carcinoma, Transitional Cell, Bladder",[242,254,255,256,257,258],"Hyperthermic Intravesical Chemotherapy","Mitomycin C","BRS Combat System","Bladder Tumor Recurrence","High-Grade Bladder Cancer","2026-05-04",{"date":261,"type":39},"2026-05-06",{"date":263,"type":22},"2026-10-15",{"date":265,"type":22},"2028-05-31",{"name":267,"class":46},"AC.TA. S.r.l.",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100448977","phase-1-study-of-2141-v11-in-people-with-non-muscle-invasive-bladder-cancer-that-did-not-respond-to-standard-treatment-100448977","NCT05126472","Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment","Phase I Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects With Bladder Cancer","Inclusion Criteria:\n\nCohorts A and B\n\n* High-grade (HG) NMIBC (HG Ta, CIS, and\u002For T1) of urothelial histology that is unresponsive to adequate BCG therapy.\n* Stage, grade, and histology must be confirmed by the MSK Department of Pathology\n* Subjects with tumors of mixed urothelial\u002Fnon-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded\n* In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy\u002FTURBT\n* In this context, adequate BCG therapy is defined as at least one of the following:\n* At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy\n* At least five of six doses of an initial induction course plus at least two of six doses of a second induction course\n* Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable:\n* Persistent or recurrent CIS alone or with recurrent Ta\u002FT1 disease (noninvasive papillary disease\u002Ftumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy\n* Recurrent HG Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy\n* HG T1 disease at the first evaluation following an induction BCG course\n\nCohort C:\n\n* Muslce invasive bladder cancer cT2-T4aN0-2 that has a predominant urothelial histology.\n* Stage, grade, and histology must be confirmed by the MSK Department of Pathology\n* Subjects with tumors of mixed urothelial\u002Fnon-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded\n\nCohort A and B Only:\n\n* In subjects with papillary tumors (Ta and T1), a complete TURBT must have been performed.\n\nThis is characterized by:\n\n* Attainment of a visually complete resection of all papillary tumors (Ta and T1)\n* Residual CIS not amenable to complete transurethral resection is acceptable\n* Receipt of restaging transurethral resection for any tumor with invasion into the lamina propria (HG T1) as part of standard care, with documented presence of uninvolved detrusor muscle.\n* Most recent cystoscopy\u002FTURBT must have been performed within 6 months of the first dose of trial treatment.\n* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy).\n* Have elected not to undergo or are considered ineligible for radical cystectomy, as determined by the treating surgeon. Reasons for ineligibility or refusal of radical cystectomy should be discussed with the subject as part of the informed consent process.\n* Ineligibility factors for radical cystectomy may include, but are not limited to:\n* Cardiovascular disease (e.g., recent acute coronary syndrome, arrhythmia, heart failure)\n* Chronic obstructive pulmonary disease that would preclude a safe surgical procedure, as determined by the treating surgeon\n* Poor performance status\n* Prior major abdominal and pelvic surgery that would preclude a safe surgical procedure, as determined by the treating surgeon\n\nCohort C Only:\n\n* Are willing to undergo a standard of care examination under anesthesia or cystoscopy within four weeks of scheduled radical cystetomy.\n* Patients must have received 3-4 cycles of neoadjuvant Enfortumab Vedotin and pembrolizumab\n* Age ≥18 years on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 \u002F Karnofsky performance status ≥60%, as assessed within 28 days prior to treatment initiation.\n* Required values for screening laboratory tests, performed within 28 days prior to treatment initiation:\n\nAbsolute neutrophil count (ANC) ≥1000\u002Fmm3\n\n* Platelets \\>75,000\u002Fmm3 without\n* Hemoglobin \\>8 g\u002FdL\n* Creatinine clearance \\>40 mL\u002Fmin for the dose-escalation phases, \\>25 mL\u002Fmin for the dose expansion phases (estimated GFR can also be used in place of creatinine clearance)\n* AST\u002FALT ≤3 times the institutional upper limit of normal (ULN)\n* Total bilirubin ≤1.5 times the institutional ULN\n\n  * Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n  * Female subjects will be considered of non-reproductive potential if any of the following:\n  * Postmenopausal \\[defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C45 years of age a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n  * Have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening\n  * Has a congenital or acquired condition that prevents childbearing\n  * Male and female subjects of childbearing potential must agree, if participating in sexual activity that could lead to pregnancy, to use of an adequate method of contraception from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of trial therapy. Subjects should be informed that taking the study medication(s) may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study.\n\nMale subjects will be considered of non-reproductive potential if they have azoospermia (whether due to vasectomy or an underlying medical condition). Female subjects will be considered of non-reproductive potential if as described above. Acceptable methods of contraception:\n\n* Single method (one of the following is acceptable): intrauterine device, vasectomy of a female subject's male partner, or contraceptive rod implanted into the skin\n* Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), or hormonal contraceptive \\[oral contraceptive pill (estrogen\u002Fprogestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\n* Male subjects must agree not to donate sperm during and after the study\n* Able to comply with the treatment schedule as determined by the participant and the licensed practitioner.\n\nExclusion Criteria:\n\n(Cohort A and B)\n\n* History of or currently being treated for muscle-invasive (T2, T3, T4) locally-advanced non-resectable or metastatic urothelial carcinoma.\n* Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma.\n* Concurrent anti-cancer therapy, including investigational agents\n\nExceptions include:\n\n* Cohorts A and B Exceptions: Subjects on topical therapy (e.g. topical 5-\n* Cohort C Exceptions: Subjects on topical therapy (e.g. topical 5-fluorouracil) and Neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine)\n* Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy\u002FTURBT to starting trial treatment (a single dose of intravesical treatment given as part of the most recent cystoscopy\u002FTURBT, during the screening period, such as with chemotherapy as per local\u002Fregional practices, is acceptable).\n* Have received any other neoadjuvant treatment other than Enfortumab Vedotin and pembrolizumab for muscle invasive bladder cancer\n* Has had prior chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent.\n\n  °Subjects with Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception to this criterion and may qualify for the study\n* Major surgery or a wound that has not fully healed within 4 weeks prior to the first dose of trial treatment.\n\n  ° If subject has undergone major surgery greater than 4 weeks prior, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting trial therapy\n* Known additional malignancy that has had progression or has required active treatment in the last three years\n\nExceptions include:\n\n* Basal cell carcinoma of the skin\n* Squamous cell carcinoma of the skin that has undergone potentially curative therapy\n* In situ cervical cancer\n* History of prostate cancer treated with definitive intent (surgical or radiation therapy), provided that the following criteria are met: stage T2N0M0 or lower with a Gleason score ≤7 and prostate-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy, that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study enrollment\n\n  * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n  * Diagnosis of immunodeficiency, concurrent immune suppressive disease, or is receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 4 weeks prior to the planned first dose of trial treatment. The use of physiologic doses of corticosteroids as replacement therapy (for adrenal or pituitary insufficiency, etc.) is acceptable. Topical and inhaled corticosteroids in standard doses are acceptable.\n  * Known contraindications to intravesical therapy:\n* Febrile illness, symptomatic urinary tract infection, or persistent gross hematuria\n* Traumatic catheterization or gross hematuria on day of treatment\n\n  * Active infection requiring systemic therapy, including active or intractable urinary tract infection within 4 weeks prior to the first dose of trial treatment\n  * Severe infection within 4 weeks prior to the first dose of trial treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n  * History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n  * History of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV-1\u002F2 antibodies).\n  * Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C \\[e.g., HCV RNA (qualitative) detected\\] infection; subjects with past\u002Fresolved Hepatitis B Virus (HBV) infection (defined as having a negative HBsAg and a positive antibody to Hepatitis B core antigen) or Hepatitis C Virus (HCV) infection are eligible only if polymerase chain reaction (PCR) testing is negative for HBV DNA or HCV RNA, respectively (must be obtained within 28 days prior to treatment initiation).\n  * Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment\n  * History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\n  * History of pulmonary embolism or any other thromboembolic event within 6 months prior to enrollment.\n  * History of undergoing an allogeneic tissue\u002Fsolid organ transplant\n  * History or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the subject's participation for the full duration of the trial, interfere with the subject's ability to cooperate with the requirements of the trial, confound the results of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator",{"count":276,"type":22},55,[59],"The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.",[28],[281,282],"2141-V11","21-314",{"date":284,"type":39},"2026-05-08",{"date":286,"type":39},"2021-11-08",{"date":288,"type":22},"2027-11",{"name":234,"class":130},7,{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":235},"100500447","phase-2-replacing-invasive-cystoscopy-with-urine-testing-for-non-muscle-invasive-bladder-cancer-surveillance-100500447","NCT05796375","Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance","ReplaceCysto","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. History of low grade intermediate-risk non-muscle invasive bladder cancer, defined as most recent pathology report showing any of the following:\n\n   * multifocal low grade non-invasive urothelial carcinoma of any size\n   * solitary low grade non-invasive urothelial carcinoma greater than 3cm in size\n   * recurrent low grade non-invasive urothelial carcinoma\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. No evidence for recurrence at cystoscopy ≤6 months after most recent tumor resection\n5. Ability to consent in English or Spanish\n\nExclusion Criteria:\n\n1. History of total cystectomy of the bladder.\n2. History of urinary diversion (e.g., neo-bladder, colon pouch, or ileal conduit).\n3. History of muscle-invasive bladder tumor.\n4. Pregnancy or lactation.\n5. History of urothelial carcinoma of the ureter or renal pelvis status post endoscopic treatment or with evidence of recurrent upper tract disease (inclusion allowed if status post nephroureterectomy and recurrence free at time of inclusion)\n6. Anatomic constraints making cystoscopy impossible (e.g., history of urethrectomy, obliterated urethra secondary to stricture).\n7. Inability to provide a voided urine sample.",{"count":299,"type":22},240,[25],"The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing. Specifically, this study examines whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.",[165],[304,305,306,307,308,309,310],"Bladder","Cancer","Urology","Cystoscopy","Xpert","EpiCheck","Urine test","2026-05-01",{"date":259,"type":39},{"date":314,"type":39},"2023-11-17",{"date":316,"type":22},"2028-12-30",{"name":318,"class":319},"White River Junction Veterans Affairs Medical Center","FED",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":5},"100439458","afu-registry-of-the-therapeutic-management-and-follow-up-of-non-muscle-invasive-bladder-cancer-100439458","NCT05002556","AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer","TVNIM-AFU","Inclusion Criteria:\n\n* Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary test (biomarker) prior to their resection (biopsy) diagnosis or recurrence,\n* AND adult (equal to or \\> 18 years old),\n* AND affiliated with a social security scheme in France,\n* AND whose monitoring will be carried out at the recruiting center.\n\nExclusion Criteria:\n\n* Patient being monitored for a non-urothelial bladder tumor\n* Patient refusing follow-up\n* Opposition to participation in the study\n* Adult protected by law",{"count":328,"type":22},8000,"The AFU has set itself the task of setting up a register of medical practices in order to define possible improvements in the therapeutic management and follow-up of NMIBC. In order to obtain representative data, all urologists who are members of the AFU may be invited to include their patients.",[331],"Non-Muscle-Invasive Bladder Cancer",[333],"Bladder cancer, urine test, recurrence","2026-04-24",{"date":336,"type":39},"2026-04-30",{"date":338,"type":39},"2023-02-21",{"date":340,"type":22},"2035-02",{"name":342,"class":130},"Association Francaise d'Urologie",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100614764","phase-2-study-of-cretostimogene-given-in-patients-with-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin-100614764","NCT07283835","Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin","A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\nIn order to be eligible for participation in this trial, the patient must:\n\n1. Be ≥18 years of age on day of signing informed consent.\n\n   \\- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta\u002FT1 papillary disease.\n2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n3. Have all Ta and\u002For T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.\n4. Demonstrate adequate organ function.\n5. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta\u002FT1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.\n6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.\n\nExclusion Criteria:\n\n1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3\u002FT4, any N) or metastatic bladder cancer.\n2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.\n3. Has received systemic anti-cancer therapy, including investigational agents.\n4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.\n5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.\n6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.",{"count":351,"type":22},16,[25],"This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta\u002FT1 papillary tumors.",[115,355],"High-grade Ta\u002F T1 Papillary Disease Bladder Cancer",[357,358,34,359],"high-grade Ta papillary disease","high-grade T1 papillary disease","Bacillus-Calmette-Guerin unresponsive",{"date":361,"type":39},"2026-04-23",{"date":363,"type":39},"2025-12-04",{"date":365,"type":22},"2028-12-31",{"name":367,"class":46},"Lepu Biopharma Co., Ltd.",14,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100608797","phase-1-a-study-to-learn-about-the-study-medicine-pf-08052667-in-people-with-bladder-cancer-100608797","NCT07206225","A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER","INCLUSION CRITERIA:\n\n1. 18 years of age or older (or the minimum age of consent per local regulations)\n2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1\u002FTa papillary disease. Note: High-grade T1\u002FTa papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3\n3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.\n4. Have refused or are ineligible or not appropriate for radical cystectomy\n5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment\n6. ECOG PS 0 or 1\n\nEXCLUSION CRITERIA:\n\n1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed\n2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol\n3. Participants with active, uncontrolled infection as specified in the protocol",{"count":377,"type":22},294,[59],"The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and\u002For a medicine called sasanlimab.\n\nThis study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them.\n\nThe study has three parts:\n\n* Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and\u002For sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and\u002For sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments.\n\nAll participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and\u002For sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.\n\nFor all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.",[28],[382,62,89,383,384,385,386,387],"NMIBC","Bladder Tumors","Bladder Neoplasms","Malignant Tumor of Urinary Bladder","Urinary Bladder Cancer","Cancer of Bladder","2026-04-20",{"date":390,"type":39},"2026-04-21",{"date":392,"type":39},"2025-11-06",{"date":394,"type":22},"2033-01-28",{"name":396,"class":46},"Pfizer",47,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":405,"phases":4,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":412,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":416,"locationsCount":418},"100550197","an-expanded-access-program-of-cretostimogene-grenadenorepvec-for-treatment-of-nmibc-for-patients-unresponsive-to-bcg-100550197","NCT06443944","An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG","An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)","Inclusion Criteria:\n\n1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following:\n\n   * Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)\n   * Completion of qualifying BCG treatment (e.g., \"5+2\" minimum exposure) within 15 months of the initial qualifying dose of BCG.\n2. Have all Ta and\u002For T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment\n3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.\n4. Acceptable baseline organ function\n\nExclusion Criteria:\n\n1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.\n2. Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed.\n3. Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1\n4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.","EXPANDED_ACCESS","This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta\u002FT1) unresponsive to BCG.",[62,408,409,89],"Urothelial Carcinoma","Urologic Cancer",[306,89,115,411],"Cretostimogene Grenadenorepvec","AVAILABLE","2026-04-13",{"date":415,"type":39},"2026-04-14",{"name":417,"class":46},"CG Oncology, Inc.",26,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":434,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"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":276,"type":22},[59],"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.",[165,382,430,431,432,433],"Non-Muscle Invasive Bladder Carcinoma","Non-Muscle Invasive Bladder Neoplasms","Non-Muscle Invasive Bladder Urothelial Carcinoma","Urothelial Carcinoma Bladder",[382,172,435,436,437,438,31,439,440],"Intramural","Belzupacap Sarotalocan","Intratumoral","urothelial","bel-sar","AU-011",{"date":442,"type":39},"2026-04-15",{"date":444,"type":39},"2022-09-26",{"date":446,"type":22},"2027-03",{"name":448,"class":46},"Aura Biosciences",17,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":101},"100554786","phase-2-a-trial-of-durvalumab-medi4736-plus-monalizumab-in-non-muscle-invasive-bladder-cancer-100554786","NCT06503614","A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer","ENHANCE (Elevated NKG2A and HLA-E Amplify NK\u002FCD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer","ENHANCE","Inclusion Criteria:\n\n1. Age ≥18 years at the time of consent.\n2. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Able and willing to provide written informed consent.\n3. Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration.\n4. Non-muscle-invasive bladder cancer\n\n   * Cohort A: CIS +\u002F- high grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG.\n   * Cohort B: High grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG.\n5. Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible. NOTE: Pathology report required for documentation purposes.\n6. Patients can have BCG-unresponsive or BCG-exposed NMIBC11. Adequate BCG therapy is defined as completing at least induction BCG (≥ 5 doses) and the first round of maintenance or second induction course BCG (≥ 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG.\n\n   * BCG-unresponsive is defined as high grade persistent or recurrent NMIBC that has not achieved a disease-free status after an adequate course of BCG therapy. This includes patients with:\n\n     * Persistent or recurrent high-grade tumors (Ta\u002FT1) or carcinoma in situ (CIS) within 6 to 12 months of completing adequate BCG therapy.\n     * Recurrent high-grade papillary disease within 6 months of BCG therapy.\n     * High-grade T1 disease found at the first evaluation after BCG induction therapy alone.\n   * BCG-exposed is defined as high grade NMIBC that has recurred after an initial response or is still present after initial treatment, but recurrence is never too late to be considered \"BCG-unresponsive\". This includes patients with:\n\n     * High-grade recurrence between 12 and 24 months after adequate BCG therapy.\n     * Recurrence within 24 months of inadequate BCG therapy.\n     * High-risk recurrence at the 3-month mark after an initial BCG induction.\n     * High grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible. The recurrence must be within 6 months of the last BCG dose.\n7. Patients may have received up to 2 lines of prior therapy (including chemotherapy or other approved agents) for NMIBC (NOTE: prior PD-1\u002FPD-L1 blockade is prohibited).\n8. Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy. NOTE: Reason for being deemed unfit or refusal should be documented in the medical record.\n9. All visible tumor must be completely resected within 60 days prior to registration (residual pure CIS is permitted).\n\n   * All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urine cytology within 28 days prior to registration (positive cytology is allowed in patients with CIS).\n10. All patients with T1 tumors must undergo restaging TURBT within 60 days prior to registration.\n\n    * There must be uninvolved muscularis propria in the restaging TURBT specimen.\n    * The initial TURBT prior to the restaging TURBT may be \\> 60 days prior to registration.\n11. Patients must have baseline tumor tissue from either initial or repeat TURBTs for submission of a minimum of 2 and up to 10 unstained slides for translational study objectives. If archival tissue is not available, the subject is not eligible.\n12. Adequate organ function as defined by ALL of the following within 28 days prior to registration:\n\n    * Absolute neutrophil count ≥ 1500\u002FµL\n    * Platelets ≥ 100,000\u002FµL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Aspartate aminotransferase\u002Falanine aminotransferase ≤ 1.5× upper limit of normal (ULN)\n    * Total serum bilirubin ≤ 1.5×ULN\\*; \\*Patients with Gilbert's disease: ≤ 3×ULN\n    * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN unless the patient is on therapeutic anticoagulation.\n    * Creatinine clearance ≥ 40 mL\u002Fmin by Cockcroft-Gault estimation. The patient's estimated CrCl will be calculated by the local laboratory (for eligibility purposes) using screening\u002Fbaseline height (m), actual weight (kg), and serum creatinine:\n\n    Males: CrCl = ((140 - age in years) × weight (kg)) \u002F (72× serum creatinine (mg\u002FdL)) Females: CrCl = ((140 - age in years) × weight (kg) ×0.85) \u002F (72× serum creatinine (mg\u002FdL))\n13. Females of childbearing potential (FOCBP) must have a negative urine or serum pregnancy test within 7 days of registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. FOCBP must agree to use contraception during the study.\n14. Men capable of fathering a child must agree to use contraception during the study.\n15. Must have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).\n2. Prior CIS of the ureters or prostatic urethra within 24 months prior to registration.\n3. Evidence of metastatic disease on imaging (CT or MRI) of the abdomen and pelvis within 90 days of registration.\n4. Body weight ≤ 30 kg.\n5. History of allogeneic organ transplantation.\n6. History of another primary malignancy other than muscle-invasive bladder cancer less than 5 years prior to Day 1 of this trial, with the exception of a malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study drug and of low potential risk for recurrence. Other exceptions include those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer (non-melanoma skin cancer) or lentigo maligna without evidence of disease, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ without evidence of disease treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate specific antigen \\[PSA\\] ≤ 10 mg\u002FmL, etc.)\n7. Currently participating in or has participated in a trial of an investigational agent within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever is longer without recovery of clinically significant toxicities from that therapy.\n8. Active or prior autoimmune or inflammatory disorders requiring systemic treatment within 24 months prior to registration. Autoimmune or inflammatory disorders include, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease(colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis),antiphospholipid syndrome, Sarcoidosis syndrome, or Wegener's syndrome (granulomatosis with polyangiitis, Graves' disease, hypophysitis, uveitis, etc), Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. NOTE: The following are exceptions to this criterion: Patients with vitiligo or alopecia, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. Any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the study physician. Patients with celiac disease controlled by diet alone.\n9. A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n10. Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n11. Active known tuberculosis.\n12. Symptomatic herpes zoster within the past 30 days.\n13. Active infection requiring systemic therapy. NOTE: Prophylactic antibiotics are permitted. Treatment for a UTI is allowed but must be deemed adequately treated by the treating physician prior the start of C1D1.\n14. History of idiopathic pulmonary fibrosis or organizing pneumonia.\n15. History of (non-infectious) pneumonitis that required steroids or have current pneumonitis.\n16. Patients known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) are eligible with the following:\n\n    * On effective anti-retroviral therapy with undetectable viral load within 6 months of registration.\n    * HIV-infected participants must not have a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n17. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. NOTE: No testing for Hepatitis B and Hepatitis C is required unless mandated by a local health authority.\n18. Participants with a known co-infection with HBV and HCV, or co-infection with HBV and HDV, namely: HBV positive (presence of HBsAg and\u002For anti HBcAb with detectable HBV DNA); AND HCV positive (presence of anti-HCV antibodies); OR HDV positive (presence of anti-HDV antibodies).\n19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n20. Received live vaccines within 30 days of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted.\n21. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n22. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n23. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n24. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.\n25. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n    * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n    * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n26. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n27. History of leptomeningeal carcinomatosis\n28. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n29. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication",{"count":459,"type":22},60,[25],"This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.",[28,432],"2026-04-02",{"date":465,"type":39},"2026-04-08",{"date":467,"type":39},"2025-02-24",{"date":469,"type":22},"2032-12-22",{"name":471,"class":130},"John Sfakianos",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":479,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":482,"studyType":86,"phases":4,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":152},"100630991","effects-of-microbiological-and-immunological-factors-on-the-lower-urinary-tract-100630991","NCT07494864","Effects of Microbiological and Immunological Factors on the Lower Urinary Tract","MiLUT","General inclusion criteria:\n\n* Women and men aged ≥ 18 years old\n* Able to give informed consent for participation in the study\n* Willing to adhere to the study protocol for the whole trial period\n* Willing to undergo repetitive in-and-out single catheterization Specific inclusion criteria for the different study arms Arm I: Healthy controls Arm II: Asymptomatic bacteriuria in subjects not requiring assisted bladder emptying Arm III: Asymptomatic bacteriuria in subjects relying on some type of catheter for bladder emptying Arm IV: Acute non-catheter associated UTIs Arm V: Recurrent non-catheter associated UTIs Arm VI: Acute catheter-associated UTI Arm VII: Recurrent catheter-associated UTI Arm VIII: Chronic pelvic pain Arm IX: Non-neurogenic overactive bladder syndrome Arm X: Non-muscle-invasive bladder cancer\n\nExclusion Criteria:\n\n* Current antibiotic treatment or antibiotic treatment within the last 21 days (except for study arms IV-VII)\n* UTI secondary to diagnosed treatable pathologies (i.e., bladder stones, enterovesical fistula etc.) and requiring specific therapy Current therapies for preventing UTIs (e.g., urine acidification, phytotherapy) or such therapies within the last 21 days (except for study arms IV-VII)\n* Deterioration of the upper urinary tract requiring medical intervention\n* Immunomodulatory therapies (apart from routine vaccination)\n* Congenital or acquired malformations of the LUT (study arm I only)\n* Immunosuppressant therapy (study arm I only)\n* Need for antiviral medication (study arm I only)\n* Significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known AIDS) or kidney disease; or active malignancy (except from bladder cancer) or any other condition as determined by history or laboratory investigation that could cause susceptibility to infections.\n* Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected to subject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.\n* Drug\u002Falcohol dependence (as defined by DSM-IV) any time during the 6 months preceding study entry.\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\\> 5 mIU\u002FmL).\n* Suspected inability to follow the procedures of the trial (e.g., language problems, psychological disorders, dementia) such that the validity of the patient's data could be compromised.\n* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.\n* Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.\n* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.",true,{"count":481,"type":22},800,"1 Year","Millions of patients of all ages suffer worldwide from diverse urinary pathologies, such as lower urinary tract (LUT) dysfunction, bladder pain syndrome, urinary tract infections (UTIs), or bladder cancer. The research project investigates the interplay between the bladder and the microbiome. The goal is to evaluate the association of microbiological and immunological factors with lower urinary tract health in humans.",[485,486,487,488,489,490,491,165],"Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying","Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter","Recurrent Non-catheter Associated UTIs","Acute Catheter-associated UTI (CAUTI)","Recurrent Catheter-associated UTI (CAUTI)","Chronic Pelvic Pain","Non-neurogenic Overactive Bladder Syndrome \u002F LUT Symptoms","2026-03-20",{"date":494,"type":39},"2026-03-27",{"date":496,"type":39},"2023-06-01",{"date":498,"type":22},"2026-11-30",{"name":500,"class":130},"University of Zurich",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":517,"leadSponsor":519,"locationsCount":235},"100534959","a-study-to-evaluate-efficacy-and-safety-of-hydeal-cyst-intravesical-instillations-in-patients-treated-with-intravesical-chemotherapy-or-immunotherapy-in-non-muscle-invasive-bladder-cancer-100534959","NCT06245603","A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer","Hydeal Cyst","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* ECOG PS 0-2\n* Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.\n* Patients candidate to BCG or MMC intravesical induction therapy.\n* Transurethral resection (TURB\u002Fre-TURB when indicated) performed in the last 12 weeks.\n* IPSS score ≤19\n* Negative urine culture within 2 weeks before T0\n* For women who are not postmenopausal (i.e., \\\u003C 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and\u002For uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period\n* Signed the study informed consent prior to any study specific procedures.\n* Will and ability to comply with the protocol\n\nExclusion Criteria:\n\n* Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue \\> 150 ml;\n* Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it.\n* Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study\n* Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.\n* Urinary tract infection requiring antibiotics\n* Have a known hypersensitivity to any substance present in the investigational device.\n* Neurogenic bladder\n* Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.",{"count":509,"type":22},200,[247],"Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria.\n\nPrior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.\n\nThe following activities and\u002For assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.\n\nBCG or MMC will be started within 1-2 weeks from randomization (within 12-14 weeks after TURB).\n\nBCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.\n\nIPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6\u002F8 (6 for BCG and 8 for MMC) of treatment.\n\n48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.\n\nBCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.\n\nAfter 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.\n\nAfter 6 and 18 weeks from instillation therapy end, a control visit will be made.\n\nA physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.\n\nControl cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.",[28],"2026-02-04",{"date":515,"type":39},"2026-02-06",{"date":71,"type":39},{"date":518,"type":22},"2027-06",{"name":520,"class":130},"Istituto Oncologico Veneto IRCCS",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":152},"100513213","phase-4-vesical-imaging-reporting-and-data-system-vi-rads-followed-by-photodynamic-trans-urethral-resection-of-bladder-tumours-pdd-turbt-to-avoid-secondary-resections-re-turbt-in-non-muscle-invasive-bladder-cancers-nmibcs-100513213","NCT05962541","Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)","Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection","CUT-less","Inclusion Criteria:\n\n1. Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.\n2. Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \\[6\\].\n3. No imaging evidence (i.e., mpMRI\u002FVI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible).\n4. Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).\n5. Fit to undergo all procedures listed in protocol.\n6. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to TURBT and\u002For Re-TURBT.\n2. Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).\n3. Preoperative evidence of metastatic disease (i.e., cN1 - N3 and\u002For cM1).\n4. Visual evidence of low-risk NMIBC (solitary tumor, \\\u003C 1 cm) before initial TURBT.\n5. Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).\n6. TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) \\[6\\].\n7. Concomitant Upper tract (kidney or ureteric) tumours on imaging.\n8. Contraindication to adjuvant intravesical BCG immunotherapy.\n9. Unfit to undergo any procedures listed in protocol.",{"count":530,"type":22},327,[532],"PHASE4","Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.\n\nMethods\u002FAims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI\u002FVI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.\n\nPerspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.\n\nImplications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.\n\nAdditionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.",[165,432,535],"High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma","2025-12-26",{"date":538,"type":39},"2025-12-31",{"date":540,"type":39},"2025-12-22",{"date":542,"type":22},"2031-12",{"name":544,"class":130},"University of Roma La Sapienza",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":553,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":290},"100464434","phase-2-a-phase-ii-trial-of-bicalutamide-in-patients-receiving-intravesical-bcg-for-non-muscle-invasive-bladder-cancer-100464434","NCT05327647","A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer","A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer","BicaBCa","Inclusion Criteria:\n\n1. Males, age 18 or greater.\n2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.\n3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist\n4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.\n5. Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.\n\nExclusion Criteria:\n\n1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.\n2. Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.\n3. Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \\> 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.\n4. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.\n5. Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.\n6. Patients who have cancer treatment ongoing or planned in the near future which can be anticipated to decrease their 2-year survival or BCa treatment plan will be ineligible.\n7. Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.\n8. Patients receiving or planning to receive coumadin therapy will be ineligible.","MALE",{"count":555,"type":22},160,[25],"This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.",[62],[560,561,562],"Bicalutamide","BCG instillation","Placebo","2025-12-17",{"date":565,"type":39},"2025-12-18",{"date":567,"type":39},"2022-06-23",{"date":569,"type":22},"2026-12-31",{"name":571,"class":130},"CHU de Quebec-Universite Laval",{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":152},"100490937","mood-alterations-in-the-patients-with-non-muscle-invasive-bladder-cancer-treated-with-bcg-100490937","NCT05672615","Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG","Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin","Inclusion Criteria:\n\n* Subjects with a pathologically confirmed non-muscle invasive bladder cancer\n* Age ≥ 18 years old\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.\n* Patients who are pregnant",{"count":580,"type":22},42,"The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.",[62],[584,585],"Bacillus Calmette-Guerin","Mood Alterations","2025-11-17",{"date":588,"type":39},"2025-11-18",{"date":590,"type":39},"2023-03-21",{"date":592,"type":22},"2028-03",{"name":594,"class":130},"Johns Hopkins University",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100576175","phase-4-chemoablation-or-bladder-resection-with-adjuvant-chemotherapy-in-recurrent-non-muscle-invasive-bladder-cancer-100576175","NCT06781879","Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer","COBRA-NMIBC","Inclusion Criteria:\n\n* Tumour recurrence after previous urothelial tumour of Ta low-grade\n* Tumours smaller than 2 cm in diameter\n* Negative urine cytology (optional)\n* ≥18 years of age\n* Ability to understand and comprehend the provided written and oral information\n* Has provided written consent\n\nExclusion Criteria:\n\n* Known history of invasive tumour of the bladder (T1+)\n* Known history of CIS of the bladder\n* Previous MMC or BCG-treatment except for single instillations following previous TURBTs\n* Known allergy or intolerance to MMC\n* Solid tumour with suspicions of invasion\n* Tumour in the bladder neck or urethra\n* Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)\n* Small bladder volume (less than 100 ml) or incontinence\n* Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group\n* Acute cystitis\n* Pregnancy or breast-feeding\n* Averse to using secure contraception with regard to men with partners and premenopausal women",{"count":603,"type":22},272,[532],"The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors (TURBT) and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumors.\n\nThe study is a natural follow-up study following the pivotal NICSA trial supported by the Danish Cancer Society that has lead to the initial change in the European guidelines. In order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored approach through a new multicenter RCT.\n\nThe investigators hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumors will result in a permanent low recurrence rate in patients with complete response, whereas patients without complete response can be selected for adjuvant BCG which theoretically is more efficient in this select patient group. This will potentially result in a more favorable long term recurrence free survival (RFS) rate compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy.\n\nThe incidence of bladder cancer in Denmark is almost 2,000 per year. Of these, 75% have non-muscle invasive bladder cancer (NMIBC). The yearly recurrence rate of NMIBC is approximately 35% and the disease is therefore one of the most costly cancers to manage on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapies",[62],[608,609,610],"Recurrence","Ta low.grade","Chemoablation","2025-09-30",{"date":613,"type":39},"2025-10-03",{"date":615,"type":39},"2025-06-01",{"date":617,"type":22},"2032-02-01",{"name":619,"class":130},"Jakob Kristian Jakobsen",8,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":629,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":4},"100608199","phase-2-efficacy-of-gemcitabine-submucosal-injection-for-preventing-recurrence-in-intermediate--and-high-risk-non-muscle-invasive-bladder-cancer-a-randomized-trial-100608199","NCT07198451","Efficacy of Gemcitabine Submucosal Injection for Preventing Recurrence in Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized Trial","Efficacy Evaluation of Submucosal Injection of Gemcitabine in Preventing Recurrence of Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized, Single-Blind, Multicenter Clinical Study","GEM-IR-NMIBC","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive) with radiologically confirmed bladder tumor and scheduled to undergo transurethral resection of bladder tumor (TURBT).\n2. Postoperative pathological confirmation of intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC).\n3. Voluntarily participate in the study and sign the informed consent form, ensuring the patient fully understands the trial purpose, risks, and right to withdraw.\n\nExclusion Criteria:\n\n1. Preoperative comorbidities including detrusor overactivity, urethral stricture, urge incontinence, stress incontinence, or overflow incontinence.\n2. Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).\n3. History of pelvic radiotherapy.\n4. Receiving systemic anti-tumor therapy for any malignant tumor.\n5. Severe cardiovascular disease, hepatic or renal insufficiency, or coagulation dysfunction.\n6. Presence of mental illness or psychological disorders that impair normal communication.\n7. Any other situation deemed by the investigator as unsuitable for participation in this clinical study.","80 Years",{"count":631,"type":22},320,[25,223],"Bladder cancer is the most common malignant tumor of the urinary system in China, and its incidence has been increasing year by year. It is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC accounts for 75% of newly diagnosed bladder cancer cases, and transurethral resection of bladder tumor (TURBT) followed by postoperative intravesical therapy is the standard treatment for NMIBC. However, the 5-year recurrence rate of NMIBC remains as high as 50%, with 20-30% of patients progressing to MIBC. MIBC is characterized by rapid progression and a high tendency for metastasis. The 5-year survival rate for patients with metastatic bladder cancer is only 5.4%. This study aims to investigate the efficacy of submucosal injection of the chemotherapeutic agent gemcitabine in preventing recurrence of intermediate- and high-risk NMIBC. Additionally, it seeks to develop software and devices related to submucosal injection to promote the clinical application of this new approach in the chemotherapeutic management of NMIBC. This research is expected to bring a revolutionary breakthrough in the standardisation of whole-process diagnosis and treatment of NMIBC, holding significant scientific value and major clinical translational importance for improving therapeutic outcomes and prognosis of bladder cancer.",[115],[636,637,638,608,639],"non muscle invasive bladder cancer","Gemcitabine","Submucosal Injection","Randomized Controlled Trial","2025-09-22",{"date":611,"type":39},{"date":643,"type":22},"2025-10",{"date":645,"type":22},"2028-06",{"name":647,"class":130},"Shanghai University of Traditional Chinese Medicine",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":679,"leadSponsor":681,"locationsCount":152},"100607533","phase-2-toripalimab--sequential-intravesical-gemcitabine-mitomycin-c-for-bcg-unresponsive-intolerant-high-risk-nmibc-open-label-randomized-phase-2-study-100607533","NCT07189793","Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive\u002F-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study","Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive\u002F-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study","OHAI-NMIBC-01","Inclusion Criteria:\n\n1. Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.\n2. Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and\u002For carcinoma in situ (CIS).\n3. BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:\n\n   1. Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);\n   2. Recurrent high-grade Ta\u002FT1 within 6 months after completion of adequate BCG;\n   3. High-grade T1 at the first evaluation after BCG induction (\\~3 months);\n   4. Ta high-grade and\u002For CIS present or recurrent at \\~3 months after receiving ≥5 BCG instillations.\n\n   Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).\n4. ECOG performance status 0-2.\n5. Adequate organ function per protocol laboratory criteria.\n6. No intravesical chemotherapy or immunotherapy between the most recent cystoscopy\u002FTURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy\u002FTURBT is allowed during screening per local practice.\n7. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2-T4).\n2. Low-grade (LG) recurrence during or after BCG therapy.\n3. Concomitant upper tract urothelial carcinoma, or lymph-node\u002Fdistant metastasis.\n4. Indwelling ureteral stent or known vesicoureteral reflux.\n5. Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.\n6. Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.\n7. Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.\n8. Prior immune checkpoint inhibitor therapy.\n9. Pregnant, planning pregnancy, or breastfeeding women.\n10. Ongoing acute or chronic systemic infection, or history of active tuberculosis.\n11. Other malignancy requiring active treatment.\n12. Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.\n\nStudy Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.",{"count":657,"type":22},106,[25],"This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with\u002Fwithout Ta\u002FT1) and (2) non-CIS cohort (high-risk Ta\u002FT1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\\~month 3), monthly maintenance continues up to 24 months or until progression\u002Funacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression\u002Funacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression\u002Funacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS\u002FHG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.",[251,661,250,331],"Carcinoma, Transitional Cell",[382,663,664,665,666,667,668,669,670,637,255,671,672,673,674],"High-Risk NMIBC","BCG-Unresponsive","BCG-Intolerant","BCG Failure","Carcinoma in Situ (CIS)","Intravesical Therapy","Ta","T1","GEM-MMC","Toripalimab","PD-1 Inhibitor","Bladder-Sparing","2025-09-17",{"date":677,"type":39},"2025-09-24",{"date":643,"type":22},{"date":680,"type":22},"2028-10",{"name":682,"class":130},"First Affiliated Hospital of Wenzhou Medical University"]