[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-bladder-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,70,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643935","phase-2-enfortumab-vedotin--pembrolizumab-induction-to-spare-the-bladder-in-mibc-100643935",false,"NCT07663747","Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC","A Phase 2 Study to Assess Efficacy of Induction Enfortumab Vedotin Plus Pembrolizumab Using a Response-adapted Approach to Spare the Bladder: FIDELIO","FIDELIO","Inclusion Criteria:\n\n1. Participants who are at least 18 years of age on the day of signing informed consent.\n2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n3. Patients with histologically confirmed cT2-4aN0-1M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and\u002For patients who are medically unfit for surgery.\n\n   Variant histology allowed, exceptions:\n   * no pure (\\>90%) squamous\n   * no \\>50% adenocarcinoma\n   * no \\>50% sarcomatoid component\n   * no \\>10% plasmacytoid component\n   * no small cell component\n4. Archival tumor tissue sample or newly obtained TURB of the bladder tumor is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n6. Have adequate organ function as defined in Table 3 below. Specimens must be collected within 14 days prior to the start of study intervention.\n7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Not of childbearing potential (see section 9.2.1) OR\n   * Of childbearing potential and:\n\n     * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 120 days (pembrolizumab) or 180 days (EV) after the last dose of study intervention and agrees not to donate ova to others or freeze\u002Fstore for her own use for the purpose of reproduction before start of study treatment. More details on contraceptive guidance can be found in section 9.2.1. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n     * Has a negative urine or serum pregnancy test within 72 hours before the first dose of study intervention. Female subjects with false positive results and documented verification of negative pregnancy status may be eligible in consultation with the sponsor.\n     * Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention (for pembrolizumab) or 180 days (EV) after the last dose of study intervention.\n\nA male participant agrees to the following during the intervention period and for at least 180 days after the last dose of EV:\n\nRefrains from donating sperm plus either:\n\n* Abstains from heterosexual intercourse as their preferred and usual lifestyle and agrees to remain abstinent\n* Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)\n\nExclusion Criteria:\n\n1. Previous pelvic irradiation\n2. Upper tract urothelial cancer\n3. Extensive carcinoma in situ (CIS) of the bladder\n4. Bilateral hydronephrosis\n5. Previous intravenous systemic therapy for bladder cancer, including chemotherapy, checkpoint inhibition or antibody-drug conjugate.\n6. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n7. Contra-indication to one of the study treatment components\n8. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n9. Has 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 the first dose of study drug.\n10. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Exceptions: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n11. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, EV and\u002For any of its excipients in drug formulations (including histidine, trehalose dihydrate, and polysorbate 20).\n12. Has active autoimmune disease that has required systemic treatment in the past 2 years. Exceptions that can still be included:\n\n    * Endocrine disease with replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n    * Patients with vitiligo, psoriasis or other mild skin disease\n    * Gout is not considered an auto-immune disease. Patients should not have had an episode of active arthritis within 30 days of start of therapy.\n13. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Ongoing sensory or motor neuropathy Grade 2 or higher.\n15. Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.\n16. A history of uncontrolled diabetes. Uncontrolled diabetes is defined as HbA1c ≥8% or HbA1c 7% to \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n17. Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Active infection requiring systemic therapy is excluded as well.\n18. Known active Human Immunodeficiency Virus infection, or tuberculosis, or other active infection:\n\n    HIV-positive patients are eligible if the following applies:\n    * Receives antiretroviral therapy (ART), without changes in drugs or dose modification, for at least 4 weeks prior to treatment and continued while enrolled on study.\n    * CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n    * No AIDS defining opportunistic infection within the past 12 months, or a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n    * In patients with a known history of hepatitis B infection, Hepatitis B surface antigen should be negative at time of screening. Patients having chronic hepatitis B are not eligible.\n    * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n19. Has not adequately recovered from major surgery or has ongoing surgical complications.\n20. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for the disease under study.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach",[27],"Urothelial Bladder Cancer","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":21},"2026-09-01",{"date":36,"type":21},"2032-04-01",{"name":38,"class":39},"The Netherlands Cancer Institute","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100541884","mpmri-compared-to-diagnostic-turbt-in-patients-with-suspected-muscle-invasive-bladder-cancer-100541884","NCT06335667","mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer","Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study","Inclusion Criteria:\n\n* Age 18 years old or greater at the time of consent.\n* Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.\n* ECOG Performance Status of 0-3.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).\n* Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Prior TURBT within 120 days of study entry.\n* Prior therapy for bladder cancer within 180 days of study entry.\n* Inability to tolerate mpMRI or associated contrast.\n* Inability to tolerate TURBT or associated anesthesia.\n* ECOG Performance Status of 4.\n* Female patient who is known to be pregnant or breastfeeding.",{"count":49,"type":21},30,[51],"NA","This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).",[27,54],"Muscle-Invasive Bladder Cancer",[56,57,58],"mpMRI","TURBT","VI-RADS score","RECRUITING","2026-04-28",{"date":62,"type":32},"2026-05-04",{"date":64,"type":32},"2024-03-27",{"date":66,"type":21},"2030-04",{"name":68,"class":39},"University of California, Irvine",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100395396","phase-2-consolidative-radiotherapy-for-metastatic-urothelial-bladder-cancer-patients-without-progression-and-with-no-more-than-three-residual-metastatic-lesions-following-first-line-systemic-therapy-100395396","NCT04428554","Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy","Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial","BLAD-RAD01","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed)\n4. Metastatic patients to regional nodes (Tx,N1-N3,M0) and\u002For distant sites (Tx,Nx,M1a-M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first regional\u002Fdistant relapse following cystectomy (with no local recurrence in the cystectomy bed)\n5. Completion of the initial phase (4-6 cycles) of 1st line metastatic treatment (systemic therapy by chemotherapy and\u002For immunotherapy by immune check-point inhibitor according to standard recommendations). Patients having started maintenance therapy are eligible.\n6. No disease progression after the initial phase of first-line metastatic systemic therapy according to RECIST v1.1\n7. No more than 3 residual distant metastatic lesions following the initial phase of first-line metastatic systemic therapy:\n\n   1. Regional nodes (below aortic bifurcation) are not included in the count of distant metastatic lesions\n   2. The number of distant residual lesions is determined on the basis of the imaging modality for tumor response assessment performed after systemic treatment according to local habits (CT-scan or 18FDG PET-CT if performed):\n\n      In case of response assessment by CT-scanner only: residual lesions are all remaining visible lesions In case of response assessment by additional 18FDG PET-CT: residual lesions are only the lesions with residual hyperfixation\n   3. Regarding distant lymph nodes metastases:\n\n      * If evaluation is performed by CT-scanner only, residual lymph nodes are considered pathological according to one or several criteria among: Short axis ≥ 1cm\u002FCentral necrosis\u002FHeterogeneous contrast enhancement\n      * Residual para-aortic nodes involvement accounts for one lesion, even if several para-aortic nodes are involved.\n      * Other nodes: each involved node accounts for one lesion.\n8. Residual distant metastases (if applicable) eligible for SBRT in terms of dose constraints to the organs at risk, with no prior radiotherapy interfering with SBRT\n9. 8 weeks or less between last cycle of the initial phase of systemic treatment and randomization\n10. No contraindication to pelvic radiotherapy\n11. Signed informed consent\n12. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n13. Patient affiliated to a Social Health Insurance in France\n\nExclusion Criteria:\n\n1. Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or neuroendocrine carcinoma of the bladder)\n2. Brain metastases before systemic treatment\n3. Liver metastases before systemic treatment\n4. Absence of target to be irradiated (i.e. previous cystectomy + no residual distant lesions following systemic treatment + no pelvic or para-aortic nodes at metastatic presentation)\n5. Patient with relapse following definitive chemoradiation of the bladder\n6. Local recurrence in the cystectomy bed following cystectomy\n7. Previous pelvic irradiation\n8. Prior radiotherapy near the residual metastatic lesions precluding ablative SBRT\n9. Active inflammatory bowel disease\n10. Contraindication to SBRT of a lesion due to organ dysfunction; in particular, patients with lung lesions and documented or suspected interstitial lung disease should not be included\n11. History of scleroderma\n12. Current or past history of second neoplasm diagnosed within the last 5 years (except basocellular carcinoma and prostate cancer incidentally discovered during previous cystoprostatetectomy and pelvic lymph node dissection and with a good prognosis \\[T stage \\\u003CpT3b and Gleason \\\u003C8 and pN- and post-operative PSA \\\u003C0.1 ng\u002FmL\\])\n13. Pregnancy or breast feeding or inadequate contraceptive measures\n14. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n15. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n16. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).\n17. Concurrent enrolment in another interventional therapeutic clinical study",{"count":79,"type":21},130,[24],"This is a Phase II, multicenter, randomized open-label and comparative study that has been designed to evaluate whether local consolidative radiotherapy in addition to standard of care improves overall survival as compared with standard of care in patients with regional and\u002For distant metastatic urothelial bladder cancer who have no disease progression and with no more than three residual distant metastatic lesions following the initial phase of first-line systemic therapy.\n\nEach patient will be followed during 4 years from the date of randomization.",[27],[84],"Urothelial bladder cancer","2025-11-14",{"date":87,"type":32},"2025-11-18",{"date":89,"type":32},"2020-06-30",{"date":91,"type":21},"2031-07",{"name":93,"class":39},"Institut Claudius Regaud",20,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100445481","longitudinal-bladder-cancer-study-for-tumour-recurrence-100445481","NCT05080998","Longitudinal Bladder Cancer Study for Tumour Recurrence","An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients","LOBSTER","Inclusion Criteria:\n\n1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.\n2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.\n3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).\n4. Able to give written informed consent\n5. Able and willing to comply with study requirements\n6. Aged 18 years or older\n\nExclusion Criteria:\n\n1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits\n2. Previous muscle invasive bladder tumour (pT2 or greater)\n3. Known pregnancy\n\nDeferral Criteria\n\n1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.\n2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.\n3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.",{"count":104,"type":21},450,"OBSERVATIONAL","Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.",[27],[109],"Recurrence","2025-11-06",{"date":112,"type":32},"2025-11-10",{"date":114,"type":32},"2022-06-08",{"date":116,"type":21},"2026-08-31",{"name":118,"class":119},"Pacific Edge Limited","INDUSTRY",7]