[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-carcinoma-bladder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-carcinoma-bladder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,50,76,103,124,154,185,213,248,283,314,340,371,399,428,456,477],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100463282","phase-2-atezolizumab-plus-etoposide-and-platinum-in-small-cell-bladder-cancer-100463282",false,"NCT05312671","Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer","Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer","Inclusion Criteria:\n\n* Histologically confirmed invasive carcinoma of the bladder with pure, or any component of, small cell or high grade neuroendocrine features with or without urothelial cancer - localized ≥ cT1-T4aN1\n\nA formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If less than 15 slides are available, the patient may still be eligible for the study, after Principal Investigator confirmation has been obtained.\n\nIf archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening.\n\n* Medically fit to undergo chemotherapy, immunotherapy and cystectomy\n* 18 years old at time of consent\n* ECOG performance status of 0 or 1\n* Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization:\n* ANC ≥ 1500 cells\u002FμL without granulocyte colony-stimulating factor support\n* Lymphocyte count ≥ 500\u002FμL\n* Platelet count ≥ 100,000\u002FμL without transfusion\n* Hemoglobin ≥ 9.0 g\u002FdL -patients may be transfused to meet this criterion.\n* INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n* AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN\n* Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.\n* Serum albumin \\>= 25 g\u002FL (2.5 g\u002FdL)\n* Negative HIV test at screening (with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>= 200\u002FµL, and have an undetectable viral load)\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.\n* Creatinine clearance \\>30. Patients receiving cisplatin must have creatinine clearance \\>50\n* For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n* Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 30 days after the final dose of cisplatin\u002F carboplatin and etoposide. Women must refrain from donating eggs during this same period.\n* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n* Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential who is not pregnant, or a pregnant female partner men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 8 months after the final dose of atezolizumab and 120 days after the final dose of etoposide. Men must refrain from donating sperm during this same period.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* Patients who give a written informed consent obtained according to local guidelines\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n\nExclusion Criteria:\n\n* No prior systemic treatment for small-cell bladder cancer (SCBC)\n* Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible). Individual cases will be discussed at investigator discretion.\n* Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.\n* Patients who have received prior systemic chemotherapy for urothelial bladder cancer.\n\nPrior BCG and intravesical chemotherapy are allowed\n\n* Any metastatic disease including leptomeningeal disease or brain metastasis on baseline brain imaging\n* Uncontrolled tumor-related pain - Patients requiring pain medication must be on a stable regimen at study entry.\n\nPatients requiring pain medication must be on a stable regimen at study entry.\n\nUncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN\n\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Individual cases can be discussed at investigator discretion. Refer to Appendix H for more details\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Patients who have undergone major surgery (e.g. intra-thoracic, intra- abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury\n* History of malignancy other than small cell bladder cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of Atezolizumab\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti- TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of Cisplatin, carboplatin or etoposide\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months of atezolizumab after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.\n* Patients who have had radiotherapy to the bladder, or radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide.",[26,27,28],"Small Cell Neuroendocrine Carcinoma of Bladder","Bladder Cancer","Urothelial Carcinoma Bladder",[30,31,32,33,34,35,36],"Small Cell Bladder Cancer","Atezolizumab","Cisplatin","Carboplatin","Platinum","Etoposide","Cystectomy","RECRUITING","2026-06-23",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":41},"2022-06-27",{"date":45,"type":20},"2029-10",{"name":47,"class":48},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100300008","phase-1-intervention-of-bladder-cancer-by-car-t-100300008","NCT03185468","Intervention of Bladder Cancer by CAR-T","Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies","Inclusion Criteria:\n\n1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)\n2. Representative tumor specimens as specified by the protocol\n3. Adequate hematologic and end organ function\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Life expectancy greater than or equal to (\\>\u002F=) 12 weeks\n6. Measurable disease, as defined by RECIST v1.1\n\nExclusion Criteria:\n\n1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment\n2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment\n3. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments\n4. Leptomeningeal disease\n5. Malignancies other than UBC within 5 years prior to Cycle 1, Day 1\n6. Pregnant and lactating women\n7. Significant cardiovascular disease\n8. Severe infections within 4 weeks prior to infusion\n9. Major surgical procedure other than for diagnosis within 4 weeks\n10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation\n11. History of autoimmune disease\n12. Prior allogeneic stem cell or solid organ transplant\n13. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n14. Positive test for human immunodeficiency virus (HIV) and\u002For active hepatitis B or hepatitis C or tuberculosis","65 Years",{"count":59,"type":20},20,[61,23],"PHASE1","This is a Phase I\u002FII and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.",[27,28],[65,66],"CAR T","Bladder","2026-06-18",{"date":38,"type":41},{"date":70,"type":41},"2025-08-01",{"date":72,"type":20},"2029-12-31",{"name":74,"class":48},"Shenzhen Geno-Immune Medical Institute",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":75},"100530264","phase-2-assessment-of-decision-tool-to-select-women-for-gynecologic-sparing-radical-cystectomy-100530264","NCT06184516","Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy","Inclusion Criteria:\n\n* Female ≥ eighteen years of age\n* Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology\n* Surgical candidate for radical cystectomy\n* Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following:\n\n  * MRI of the pelvis on 1.5T or higher strength magnet.\n  * T2 weighted imaging in multiple planes.\n  * T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency)\n* Cystoscopic evaluation completed by urologist within 120 days prior to surgery (ROS-RC or RC)\n* Staging imaging within 90 days prior to surgery (ROS-RC or RC). If receiving neoadjuvant therapy prior to surgery (ROS-RC or RC), repeat staging imaging must be completed after the neoadjuvant therapy is completed, or no longer tolerated by the patient.\n* Staging imaging must include MRI of the pelvis within 90 days of surgery (ROS-RC or RC)\n* Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.\n* Presence of at least one or more ancillary organs. Ancillary organs defined as anterior vagina, uterus, fallopian tubes (only 1 tube present will be considered at physician discretion), and ovaries.\n* ECOG Performance Status of 0-2\n\nExclusion Criteria:\n\n* Patients with regional or distant metastatic disease\n* Non-urothelial bladder cancer.\n* Not a surgical candidate for radical cystectomy\n* Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.\n* Subjects of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.\n* Patients with other known active malignancies which may confound the recurrence rates\n* Patients with known germline mutations in DNA damage repair genes (BRCA1\u002FBRCA 2)\n* Prisoners or subjects who are involuntarily incarcerated.\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects demonstrating an inability to comply with the study and\u002For follow-up procedures.\n* Subjects who are confirmed to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for complications, in the opinion of the treating physician.\n* Administration of a vaccine containing live virus within 30 days prior to the study intervention. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.","FEMALE","99 Years",{"count":85,"type":20},127,[23],"Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.",[28],[90,91,92,93],"urothelial carcinoma","radical cystectomy","organ preservation","female","2026-06-04",{"date":96,"type":41},"2026-06-08",{"date":98,"type":41},"2024-08-30",{"date":100,"type":20},"2028-03",{"name":102,"class":48},"University of Florida",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":75},"100561138","phase-1-adjuvant-concurrent-immunotherapy-and-radiotherapy-for-the-treatment-of-bladder-cancer-100561138","NCT06586255","Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer","Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer","Inclusion Criteria:\n\n* Pure or mixed variant urothelial carcinoma\n\n  o Allowable mixed variant subtypes include:\n  * squamous differentiation\n  * glandular differentiation\n  * nested pattern\n  * microcystic\n  * micropapillary\n  * lymphoepthelioma-like\n  * plasmacytoid and lymphoma-like\n  * sarcomatoid\u002Fcarcinosarcoma\n  * giant cell\n  * trophoblastic differentiation\n  * clear cell\n  * lipid cell\n  * undifferentiated\n* Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks\n* Pathologic T3 or higher stage disease, any N, M0 (AJCC, 7th Ed., Appendix C)\n* Receiving adjuvant checkpoint inhibitor therapy\n* No clinical evidence of residual or recurrent disease based on the following minimum diagnostic work-up within 3 months of a patient's consent to participate.\n\n  * History and physical examination\n  * Chest imaging by x-ray (PA and lateral views), CT scan (with or without IV contrast) or as part of a FDG PET-CT;\n  * Axial abdominal and pelvic imaging by MRI (preferably with gadolinium), CT scan (with or without IV contrast) or as part of a FDG PET-CT;\n  * Patients with microscopically involved (positive) surgical margins, but no grossly evident residual disease by imaging or physical exam are eligible.\n* The patient is a candidate for definitive external beam radiotherapy;\n\n  * No prior radiotherapy to the region of study;\n  * No inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist;\n* Age greater than or equal to 18 years\n* ECOG performance status: 0-2\n* Concurrent non-investigational medications will be permitted\n* In addition to diagnostic staging scan, patient will be considered eligible only if he\u002Fshe has a CT simulation scan that does not show any evidence of recurrent disease\n* Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility)\n\nExclusion Criteria:\n\n* Urinary diversion with an orthotopic neobladder\n* History of inflammatory bowel disease\n* Prior partial or complete small bowel obstruction either before or after radical cystectomy\n* Prior radiotherapy to the pelvis;\n\n  o Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participant's prior and current course of radiation therapy, radiotherapy was completed more than four weeks from enrolling in this study.\n* Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments\n\n  o Prior chemotherapy or investigational drug for bladder cancer or a different cancer is allowed, provided that:\n  * The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation\n  * The participant has recovered to Grade ≤1 toxicity from agents previously administered, excluding toxicities that would not be expected to impact eligibility for radiation therapy including but not limited to neuropathy, alopecia and hearing loss.\n* Subtotal surgical resection with clinically evident residual disease by physical exam or axial imaging.\n* Prior or concurrent second invasive malignancy that, in the judgment of the investigator, may affect interpretation of the results.\n* Known severe, active co-morbidity, defined as follows:\n\n  o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results.\n* Patients who experienced Grade 3+ GI toxicity due to surgery or nivolumab prior to enrollment in the trial",{"count":111,"type":20},10,[61],"The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.",[28,27],"2026-05-12",{"date":117,"type":41},"2026-05-14",{"date":119,"type":41},"2025-04-29",{"date":121,"type":20},"2027-04",{"name":123,"class":48},"Abramson Cancer Center at Penn Medicine",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":75},"100578035","preoperative-physical-activity-before-radical-cystectomy-and-the-impact-on-morbidity-100578035","NCT06806059","Preoperative Physical Activity Before Radical Cystectomy and the Impact on Morbidity","Prospective Randomized Interventional Study to Investigate the Impact of Preoperative Physical Activity on Perioperative Morbidity Following Radical Cystectomy","PRACTICE","Inclusion Criteria:\n\n* Urothelial cell cancer of the bladder\n* Treatment with radical cystectomy\n\nExclusion Criteria:\n\n* Need for walking aid\n* Depression\n* cardiovascular, neuromuscular or orthopaedic deficites \u002F disorders\n* Time to surgery \\\u003C 3 Weeks",{"count":133,"type":20},146,[135],"NA","Bladder cancer (BC) is the 6th most common tumor in Europe, with over 540,000 new cases globally each year. While 75% of cases are non-muscle-invasive and treated bladder-preservingly, muscle-invasive, non-metastatic BC requires radical cystectomy (RC), often with neoadjuvant chemotherapy. RC has one of the highest complication rates in urology, and rehabilitation focuses on mitigating functional impairments, restoring physical and mental capacity, and enabling a swift return to daily life.\n\nThe ERAS (Enhanced Recovery After Surgery) protocol has shown benefits in reducing hospital stays without increasing complications in RC. Prehabilitation studies in cancer patients have demonstrated improvements in strength and fitness, though without significant reductions in complications or mortality.\n\nThis prospective randomized study, conducted over three years at the University of Munich, will evaluate the effect of preoperative physical activity on perioperative morbidity (primary endpoint). Secondary endpoints include quality of life, hospital stay, mortality, and postoperative physical activity. The intervention group will target 8,000-10,000 daily steps for four weeks preoperatively, monitored via pedometers. Follow-ups will assess physical activity and quality of life at specific intervals pre- and post-surgery.",[28],[139,140,141,142,143,144],"physical activity","preoperative","cystectomy","activity tracker","physical fitness","complication","2026-04-22",{"date":147,"type":41},"2026-04-27",{"date":149,"type":41},"2024-11-29",{"date":151,"type":20},"2027-11-29",{"name":153,"class":48},"Ludwig-Maximilians - University of Munich",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100635675","phase-1-calcium-electroporation-for-urinary-bladder-tumors-a-first-in-human-feasibility-safety-and-early-response-trial-100635675","NCT07555769","Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial","Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial","CALCIFER","Inclusion Criteria:\n\n* Age ≥ 18 years and able to understand participant information and give informed consent\n* Histologically verified urothelial bladder tumor\n* Unfit for cystectomy and\u002For radiotherapy\n* Patients with recurrence after radiotherapy unfit for salvage cystectomy\n* Disease where other treatments are considered unsuitable or have been declined by the patient\n* The patient may receive simultaneous systemic treatment\n* Selected high-burden non-muscle-invasive bladder tumors after MDT assessment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n* Life expectancy of ≥ 3 months\n* Patients must be deemed able to tolerate general anesthesia\n* Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization\n* Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines\n* Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed\n* Hematology\n\n  * Thrombocytes ≥ 50 billion\u002FL\n  * International normalized ratio (INR) ≤ 1.5. Correction is allowed\n\nExclusion Criteria:\n\n* Pregnancy (confirmed by a blood sample) or lactation\n* Allergy to calcium gluconate or any of its excipients\n* Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible\n* Contraindications to treatment with calcium gluconate as described:\n\n  * Hypersensitivity to calcium gluconate or any of its excipients\n  * Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)",{"count":59,"type":20},[61],"This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.",[166,167,168,28],"Bladder Tumors","Bladder Tumor","Urothelial Carcinoma (UC)",[170,171,172,173,174],"calcium electroporation","electroporation","transurethral electroporation","bladder tumors","urothelial tumor","NOT_YET_RECRUITING","2026-04-21",{"date":178,"type":41},"2026-04-29",{"date":180,"type":20},"2026-06",{"date":182,"type":20},"2030-04",{"name":184,"class":48},"Juan Luis Vásquez",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":212},"100594490","phase-1-a-study-of-225acac-aky-1189-in-patients-with-solid-tumors-100594490","NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity",{"count":193,"type":20},150,[61],"This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[28,197,198,199,200,201,202],"Triple Negative Breast Cancer (TNBC)","Hormone Receptor Positive Breast Adenocarcinoma","Non Small Cell Lung Cancer","Cervical Adenocarcinoma","Colorectal Adenocarcinoma","Head and Neck Cancer","2026-04-17",{"date":176,"type":41},{"date":206,"type":41},"2025-08-22",{"date":208,"type":20},"2032-06",{"name":210,"class":211},"Aktis Oncology, Inc.","INDUSTRY",9,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":230,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":5},"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":221,"type":20},55,[61],"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.",[225,226,227,228,229,28],"Non-muscle-invasive Bladder Cancer","NMIBC","Non-Muscle Invasive Bladder Carcinoma","Non-Muscle Invasive Bladder Neoplasms","Non-Muscle Invasive Bladder Urothelial Carcinoma",[226,231,232,233,234,235,236,237,238],"TURBT","Intramural","Belzupacap Sarotalocan","Intratumoral","urothelial","bladder cancer","bel-sar","AU-011","2026-04-13",{"date":241,"type":41},"2026-04-15",{"date":243,"type":41},"2022-09-26",{"date":245,"type":20},"2027-03",{"name":247,"class":211},"Aura Biosciences",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":257,"type":20},60,[61],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[261,262,263,264,265,266,267,268,269,270,271,28,272],"Solid Tumor, Adult","Microsatellite Stable Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Cervical Cancer","Kidney Cancer","Renal Cell Carcinoma","Melanoma Stage IV","Merkel Cell Carcinoma of Skin","Mesothelioma","Non-small Cell Lung Cancer","Cutaneous Squamous Cell Carcinoma (CSCC)","Squamous Cell Carcinoma","2026-04-01",{"date":275,"type":41},"2026-04-07",{"date":277,"type":41},"2024-09-16",{"date":279,"type":20},"2027-12-31",{"name":281,"class":211},"KaliVir Immunotherapeutics",7,{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":295,"conditions":296,"keywords":301,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100442122","phase-3-evaluating-safety-and-efficacy-of-verity-bcg-in-bcg-nave-patients-with-intermediate-and-high-risk-non-muscle-invasive-bladder-nmibc-100442122","NCT05037279","Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)","A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.","EVER","Inclusion Criteria:\n\n* Male or Female\n* 18 years and older\n* Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)\u002FInternational Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of registration.\n* Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.\n\n  1. Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.\n  2. For patients with stage T1 disease, a repeat TURBT must be performed as per standard of care\u002FCUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60 days of the initial TURBT and within 45 days of registration. Pathological confirmation is required after the repeat TURBT.\n* Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.\n* ECOG performance status of 0-2\n* Adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after the last dose of the study treatment. Note: The use of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse 120 days after last dose of study drug treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n* Note: A woman of non-childbearing potential is defined as follows:\n\n  * Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);\n  * Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).\n* Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception.\n\nMale patients must agree to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be performed outside the window it will be up to the physicians' discretion to re-scan\u002Fbiopsy. This is considered T4 disease.\n* CIS only disease.\n* Pure squamous cell carcinoma or adenocarcinoma.\n* Presence of micropapillary components.\n* Other prior non-bladder malignancy, except for the following:\n\n  * patients presenting with NMIBC recurrent tumor(s)\n  * adequately treated basal cell or squamous cell skin cancer.\n  * in situ cervical cancer.\n  * adequately treated stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease free for five years.\n  * patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.\n* Prior intravesical BCG or intradermal BCG, within 5 years of screening, with the exception of tuberculosis vaccination in childhood.\n* Chronic administration of steroids (\\>10 mg prednisone) at the time of randomization.\n* Current or planned concomitant biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.\n* Prior chemoradiation treatment (trimodal therapy or \"TMT\") for bladder cancer.\n* Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.\n* Receiving any other investigational agents.\n* The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.\n* Known positive HIV serology with detectable viral load.\n* Current diagnosis of AIDS\n* Presence of a urinary tract infection; treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.\n* Trauma to the urinary bladder. In case of gross hematuria, therapy should be stopped or postponed until the hematuria has been successfully treated or has resolved.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.\n* Uncontrolled intercurrent illness.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnancy: pregnant women are excluded from this study because VERITY-BCG is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with VERITY-BCG, breastfeeding should be discontinued if the mother is treated with VERITY-BCG.",{"count":292,"type":20},540,[294],"PHASE3","The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.",[27,297,298,28,299,300],"Bladder Cancer Recurrent","Neoplasm Recurrence","Urothelial Carcinoma Recurrent","Non-Invasive Bladder Urothelial Carcinoma",[302,303],"Interventional","Non-inferiority study","2026-03-17",{"date":306,"type":41},"2026-03-20",{"date":308,"type":41},"2024-04-24",{"date":310,"type":20},"2029-02",{"name":312,"class":211},"Verity Pharmaceuticals Inc.",6,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100628630","phase-3-a-study-of-ndv-01-sustained-release-gemcitabine-docetaxel-in-participants-with-non-muscle-invasive-bladder-cancer-100628630","NCT07464145","A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer","A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)","RESCUE","Cohort 1 Inclusion Criteria:\n\n1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA\u002FSUO criteria of IR NMIBC (excluding LGT1 tumors).\n3. Participant must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence\u002Fprogression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.\n4. Participant must have ≥ 1 IBCG risk factors: 1) multiple tumors, 2) early recurrence (within 1 year), 3) frequent recurrences (\\> 1 per year), 4) tumor size (\\> 3 cm), 5) failure of prior induction intravesical therapy.\n5. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced cystoscopic method \\[e.g., blue light cystoscopy, narrow-band imaging\\]).\n\n   All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nCohort 1 Exclusion Criteria:\n\n1. Histologically confirmed stage T1 tumors.\n2. Histologically confirmed diagnosis of HR NMIBC (including CIS) or muscle-invasive bladder cancer (MIBC), locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.\n3. Has had urothelial carcinoma outside of the urinary bladder (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of urothelial carcinoma (UC). Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.\n4. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).\n5. N+ and\u002For M+ per computed tomography (CT)\u002Fmagnetic resonance (MR) urography.\n6. Received an investigational treatment for bladder cancer within 6 months prior to randomization, before the planned first dose of study treatment, or is currently enrolled in an investigational study.\n7. Received adjuvant induction intravesical chemotherapy within 3 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy is allowed per institutional guidelines.\n8. Received prior intravesical treatment with immunotherapy, including BCG, within 3 months prior to randomization.\n\nCohort 2 Inclusion Criteria:\n\n1. Cohort 2a: BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta\u002FT1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have received 1 or 2 lines of therapy after meeting criteria for BCG unresponsiveness and experienced biopsy confirmed CIS disease within 12 months of last treatment, where:\n\n   * Adequate BCG regimen consists of at least 2 courses of BCG, where the first course (induction) must have included at least 5 of 6 doses and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of 3 doses). Adequacy of the BCG regimen will be determined by the Investigator in conjunction with the Sponsor.\n   * Treatment after BCG unresponsiveness includes either approved or in development therapy\n   * Post-treatment presence of CIS must be documented or indicated by pathology at screening or within 4 months of screening (provided no therapy for CIS disease was given after the most recent biopsy).\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n2. Cohort 2b: BCG-unresponsive NMIBC of the bladder, with papillary Ta\u002FT1 tumor(s) and without co-existing CIS, who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced recurrent Ta\u002FT1 disease within 12 months of treatment with 1 or 2 lines of therapy after BCG-unresponsive status.\n\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n\nAll Cohort 2\n\n1. A participant with HG T1 may be eligible after repeat-TURBT showing non-invasive (Ta or less) or no disease. Either original or repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen.\n2. All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. A participant with less than 10% micropapillary histology will be included. All other variant histology (e.g., plasmacytoid, small cell, nested, trophoblastic variants) will not be included.\n\nCohort 2 Exclusion Criteria:\n\n1. Has had urothelial carcinoma outside of the urinary bladder (i.e., urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and is considered to be without evidence of recurrent disease.\n\n   * Participants have tumor(s) involving the prostatic urethra (ductal or stromal).\n   * N+ and\u002For M+ per computerized tomography (CT)\u002FMagnetic Resonance Imagery (MR) urography.\n2. History of prior T2\u002FT3 urothelial carcinoma of the bladder.\n3. Concurrent treatment with any chemotherapeutic agent.\n4. Intravesical chemotherapy within 3 months of enrollment (including INLEXZO®, gemcitabine-docetaxel)",{"count":323,"type":20},393,[294],"Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts:\n\n* Cohort 1: a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC.\n* Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC:\n\n  * Cohort 2a: will include participants with HR-NMIBC who have a biopsy-proven recurrence with CIS ± papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n  * Cohort 2b: will include participants with high-risk papillary-only disease (without CIS) NMIBC who have a biopsy-proven recurrence with HG papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n\nThis study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.",[327,328,28,299,329],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)","Urologic Cancer",[226,331,236],"non-muscle-invasive bladder cancer","2026-03-05",{"date":334,"type":41},"2026-03-11",{"date":180,"type":20},{"date":337,"type":20},"2032-09",{"name":339,"class":211},"Relmada Therapeutics, Inc.",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":350,"phases":4,"briefSummary":351,"conditions":352,"keywords":357,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100578964","bladder-epicheck-european-haematuria-study-100578964","NCT06818136","Bladder EpiCheck European Haematuria Study","Evaluation of the Efficacy of Bladder EpiCheck® for the Primary Detection of Urothelial Carcinoma in Subjects Presenting With Haematuria","Inclusion Criteria:\n\n1. Participants aged 45 years or older\n2. Participants who are willing and able to provide written informed consent and adhere to study procedures\n3. Participants presenting with visible and\u002For non-visible haematuria within 6 months prior to study enrollment\n4. Participants scheduled to undergo standard of care cystoscopy for urinary bladder examination within 60 days after study enrollment\n5. Participants who are able to produce at least 10 ml of voided urine\n\nExclusion Criteria:\n\n1. Participants with history of urothelial cancer in the bladder and\u002For upper urinary tract\n2. Participants who had prior cystoscopy for haematuria within the past 2 years\n3. Participants previously enrolled in this study\n4. Participants treated for prostate cancer within the last 12 months\n5. Participants treated for kidney cancer within the last 12 months\n6. Participants with untreated urinary tract infection\n7. Participants with symptomatic urinary tract stones (e.g. flank pain)\n8. Participants on dialysis for end stage renal failure\n9. Participants with a long term urinary catheter\n10. Pregnancy (self-reported)\n11. Participants who, because of medical status, or frailty is not expected to be able to complete the full diagnostic pathway","45 Years",{"count":349,"type":20},800,"OBSERVATIONAL","The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria, compared to cystoscopy and pathology, if performed.\n\nParticipants will provide a voided urine sample, and data from standard of care haematuria work-up will be collected.",[353,354,28,355,356],"Hematuria","Cystoscopy","Urothelial Carcinoma of the Renal Pelvis and Ureter","Urothelial Carcinoma of the Urinary Bladder",[358,359,360],"urine test","methylation","primary detection","2026-01-21",{"date":363,"type":41},"2026-01-22",{"date":365,"type":41},"2025-06-20",{"date":367,"type":20},"2026-12",{"name":369,"class":211},"Nucleix Ltd.",5,{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":21,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":49},"100489677","phase-2-renal-retention-in-high-grade-upper-tract-urothelial-cancer-100489677","NCT05656235","Renal Retention in High Grade Upper Tract Urothelial Cancer","Renal Retention in High Grade Upper Tract Urothelial Cancer: A Phase II Trial of Enfortumab Vedotin and Pembrolizumab in Patients With Upper Tract Urothelial Cancer (UTUC) Who Are Not Candidates for, or Refuse, Nephroureterectomy","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of histologically documented, high grade upper tract urothelial cancer, (UTUC can be diagnosed by direct visualization and biopsy, or by 3 dimensional imaging and positive urine cytology) will be enrolled in this study.\n2. Patients must refuse definitive radical nephroureterectomy (RNU), or be medically ineligible for surgery. To be medically ineligible, patients must, in the opinion of the clinical team, be at high risk of complications intra or perioperative which would adversely impact morbidity and mortality, including risk of CKD and ESRD.\n3. Subjects must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma (in other locations such as the bladder or contralateral ureter or renal pelvis) with the following exceptions:\n\n   1. Subjects who received neoadjuvant chemotherapy with recurrence \\>12 months from completion of therapy are permitted\n   2. Subjects that received adjuvant chemotherapy following cystectomy with recurrence \\>12 months from completion of therapy are permitted\n4. Subjects may have radiographic evidence of N1 disease (Metastasis ≤2 cm in greatest dimension, in a single lymph node)\n5. Subjects must be age 18 years or older.\n6. Archival tumor tissue will be used for eligibility.\n7. Subjects must have an ECOG Performance Status score of 0 or 2\n8. Subjects must have adequate hematologic and organ function as defined by the baseline laboratory values in Table 3. Transfusion of red blood cells to meet eligibility criteria is allowed.\n\n   Table 3 - Baseline Laboratory Values\n\n   Hematological:\n\n   ANC: ≥1500\u002FμL Platelets: ≥100,000\u002FμL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\n   Hepatic:\n\n   Total Bilirubin: ≤1.5× ULN AST (SGOT) and ALT (SGPT): No adjustment in the starting dose is required when administering PADCEV to patients with mild hepatic impairment (total bilirubin 1 to 1.5 × ULN and AST any, or total bilirubin ≤ULN and AST \\>ULN).\n9. A female subject of childbearing potential is anyone born female who has experienced menarche and who has not undergone surgical sterilization (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes. Female subjects of childbearing potential must meet the following conditions:\n\n   * Agree not to try to become pregnant during the study and for at least 6 months after the final dose of study drug.\n   * Must have a negative urine or serum pregnancy test (minimum sensitivity of 25 mIU\u002FmL or equivalent units of beta human chorionic gonadotropin \\[β-hCG\\]) within 1 day prior to administration of study drug. Female subjects with false positive results and documented verification of negative pregnancy status are eligible for participation.\n   * If heterosexually active, must consistently use highly effective methods of birth control, with a failure rate of less than 1% (as described in Appendix L) starting at screening, throughout the study period, and for at least 6 months after the final dose of study drug.\n   * Female subjects must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 6 months after the final dose of study drug.\n10. A male subject who can father children is anyone born male who has testes and who has not undergone surgical sterilization (e.g., vasectomy followed by a clinical test proving that the procedure was effective). Male subjects who can father children, must meet the following conditions:\n\n    * Must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final dose of study drug. Male subjects will be informed about the negative risk to reproductive function and fertility from the study treatment. Prior to treatment male subjects should be advised to seek information on fertility preservation and sperm cryoconservation.\n    * Must consistently use highly effective methods of birth control, with a failure rate of less than 1% (as described in Appendix L) starting at screening and continue throughout study period and for at least 6 months after the final dose of study drug.\n    * Male subjects with a pregnant or breastfeeding partner(s) must consistently use one of 2 contraception options for preventing secondary exposure to seminal fluid (as described in Appendix L) for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for at least 6 months after the final dose of study drug.\n11. Subjects must provide written informed consent.\n\nExclusion Criteria:\n\n1. Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs.\n2. Subjects who have received prior treatment with a PD-(L)-1 inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1inhibitor (including, but not limited to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab).\n3. Subjects who have previously received any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor (including but not limited to CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists).\n4. Subjects who have received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment (ongoing hormonal\u002Fanti hormonal treatment, e.g., for breast cancer, is allowed, provided that the subject is eligible per exclusion criteria 14).\n5. Subjects with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \\\u003C8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n6. Subjects with an estimated life expectancy \\\u003C12 weeks\n7. Subjects with ongoing sensory or motor neuropathy Grade 2 or higher.\n8. Subjects with ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to ≤ Grade 1 or returned to baseline.\n9. Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of treatment initiation. Routine antimicrobial prophylaxis is permitted.\n10. Subjects who have known active hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] detected) infection, testing for hepatitis B and hepatitis C is required if mandated by country health authority. Subjects who have been curatively treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks.\n11. Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.\n12. Subjects with conditions requiring high doses of steroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for subjects with adrenal insufficiency.\n13. Subjects with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Subjects that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.\n14. Patients may have a history of resected urothelial cancer of the bladder or contralateral upper tract, (including neoadjuvant chemotherapy) in the following categories. These disease states are not exclusions and patients with this history will have this recorded and be considered for study on a case by case basis:\n\n    * pT0, Tis, or T1N0 and have no evidence of disease (NED) for more than 2 years from surgery or chemotherapy;\n    * pT2-3aN0 and NED for more than 3 years from surgery or chemotherapy; or\n    * \\>pT3b, or N+ and NED for more than 5 years from surgery or chemotherapy.\n    * Patients with concomitant HG UTUC bilaterally will be considered for protocol on a case by case basis.\n15. Subjects with a documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to treatment initiation (Appendix D).\n16. Subjects who have received radiotherapy within 2 weeks prior to treatment initiation. Subject must have recovered adequately from the toxicity from the intervention prior to starting study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n17. Subjects who have received major surgery within 4 weeks prior to treatment initiation. Subject must have recovered adequately from complications from the intervention prior to starting study treatment.\n18. Subjects with known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20). Subjects with known severe (≥ Grade 3) hypersensitivity to any pembrolizumab excipient contained in the drug formulations of pembrolizumab. Subjects with known severe (≥ Grade 3) hypersensitivity to the platinum agent selected by the investigator for study treatment. Subjects with known severe (≥ Grade 3) hypersensitivity to the gemcitabine.\n19. Subjects with active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.\n20. History of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n    1. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n    2. Brief (\\\u003C7 days) use of systemic corticosteroids is allowed when use is considered standard of care.\n    3. Subjects with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded.\n    4. Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.\n    5. Subjects with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded.\n21. Subjects with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n22. Subjects who have received a prior allogeneic stem cell or solid organ transplant.\n\n    Subjects who have received a live vaccine or live-attenuated vaccine within 30 days prior to treatment initiation. Administration of killed vaccines is allowed.\n\n    Note: Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n23. 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.\n24. Subjects with active tuberculosis\n25. Subjects with another underlying medical condition that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.",{"count":59,"type":20},[23],"This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0\u002FNxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0\u002FNxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.",[382,27,28],"High Grade Urothelial Carcinoma",[384,385,386,387,388,389,390],"Renal Retention in UTUC","High Grade UTUC","refusing nephroureterectomy","Enfortumab vedotin","Padcev","Pembrolizumab","Keytruda","2026-01-07",{"date":393,"type":41},"2026-01-08",{"date":395,"type":41},"2024-11-25",{"date":397,"type":20},"2029-06",{"name":47,"class":48},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":75},"100591652","phase-2-clinical-trial-of-am80-in-combination-with-gemcitabine-cisplatin-and-nivolumab-in-patients-with-urothelial-carcinoma-100591652","NCT06983210","Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma","Multi-center, Open-Label, Single Arm Trial for Evaluation of the Efficacy and Safety in the First Line Combination Therapy of Gemcitabine, Cisplatin and Nivolumab With Additional Pretreatment of AM80 for Urothelial Carcinoma Patients","GRAPE","Inclusion Criteria:\n\n1. Patients who have been histologically or cytologically diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra based on the General Rule for Clinical and Pathological Studies on Renal Pelvic, Ureteral and Bladder Cancer, 2nd Edition that cannot be curatively resected or has recurred (diagnosis is not permitted at the site of palliative radiation)\n2. Patients who have not received prior treatment for unresectable or recurrent urothelial carcinoma\n3. Patients with measurable lesions according to RECIST version 1.1 on the CT at screening\n4. Patients with an ECOG PS of 0-1 at screening, who are able to take oral medication\n5. Patients who will be expected to survive for 12 weeks or more from the enrollment\n6. Patients whose major organ functions at screening meet the following criteria\n\n(1)Neutrophil count: 1,500\u002FuL or more (2)Platelet count: 100,000\u002FuL or more (3)Hb: 9.0 g\u002FdL or more (no red blood cell transfusion within 14 days prior to screening examination) (4)T-Bil: 1.5 times or less than 1.5 times the upper limit of the facility standard value (less than 3.0 mg\u002FdL in the case of Gilbert syndrome) (5)AST and ALT: 3 times or less than 3 times the upper limit of the facility standard value (6)CrCl 50 mL\u002Fmin or more 7.Patients who have given consent to be treated if any of the following applies:\n\n1. Female patients of childbearing potential who can prevent contraception for 30 days prior to enrollment and for 2 years after the end of AM80 treatment\n2. Male patients with partners of childbearing potential, who can use contraception from the start of AM80 administration until 7 months after the end of administration and refrain from donating sperm during the above period 8.Patients aged 18-79 years at the time of consent (regardless of sex) 9.Patients who have received a thorough explanation of this clinical trial and have voluntarily given their written informed consent\n\nExclusion Criteria:\n\n1. Patients who have previously been treated with drugs such as antibodies targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137\n2. Patients who have received any of the following t reatments for urothelial carcinoma:\n\n(1)Perioperative adjuvant therapy for curative resection completed less than 12 months prior to enrollment (2)Intravesical therapy within 28 days prior to enrollment (3)Palliative radiation therapy for measurable lesions within 14 days prior to enrollment 3.Patients who have not recovered from toxicity (Grade 1 or 0 or at baseline) from prior treatment at the time of enrollment; however, enrollment is permitted for those with \\\u003C= Grade 2 fatigue and alopecia 4.Patients who have participated in other clinical trials within 28 days prior to enrollment (enrollment is permitted if the drug or medical device used in the clinical trial are similar to approved indications, dosage, and administration and do not affect the evalu ation) and who have received their last dose of a drug or other substance used in the current clinical research within the last 28 days 5.Patients with metastasis to the central nervous system or a history or complication of carcinomatous meningitis 6.Patients with multiple cancers whose disease-free interval at the time of registration is less than 3 years (excluding gastrointestinal cancer that was completely resected via endoscopic mucosal resection, completely resected intraepithelial neoplasia of the cervix, localized or presumably cured prostate cancer, completely resected basal\u002Fsquamous cell carcinoma of the skin, and solid cancers similar to these that have undergone curative treatment and are presumed to be cured) 7.Patients who are taking vitamin A agents or vitam in A-containing supplements at the time of enrollment 8.Patients who have undergone surgery under general anesthesia (excluding diagnostic biopsies) or severe trauma within 28 days prior to enrollment 9.Patients known to have a bleeding tendency or coagulation disorder (e.g., patients with significant in tratumoral bleeding, thromboembolism, or a history or comorbidity of bleeding disorders), and those who require administration of anticoagulants or antiplatelet drugs 10.Patients with active infections requiring systemic administration of antibiotics, antifungals, or antivirals 11.Patients who test positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody and RNA, or HIV antigen or antibody. However, even if the patient is negative to HBs antigen, if the patient is positive to HBs antibody or hepatitis B core (HBc) antibody, the possibility of inclusion should be considered in consultation with a gastroenterologist, if necessary, based on Document 3 of the latest Hepatitis B Treatment Guidelines.\n\n12.Patients with a history of or comorbidity of interstitial lung disease evident on imaging, or those with active non-infectious pneumonitis 13.Patients with autoimmune disease, a history of chronic or recurrent autoimmune disease, or those who have required high-dose systemic corticosteroids (prednisolone equivalent of more than 10 mg\u002Fday) or immunosuppressants within 14 days prior to enrollment 14.Patients who require treatment for tuberculosis 15.Patients with clinical symptoms or findings indicating intestinal obstruction requiring intravenous or total parenteral nutrition, and those with risk factors for intestinal perforation (e.g., acute diverticulitis, in traperitoneal abscess, gastrointestinal obstruction, history of abdominal tumor, etc.).\n\n16.Patients with gastrointestinal disorders that may affect the absorption of AM80 17.Patients with a history of severe hypersensitivity or anaphylactic reactions to components of the drugs used in the clinical trial or antibody preparations 18.Patients who received live or attenuated vaccines within 30 days prior to enrollment 19.Patients with serious complications (liver disease , kidney disease, heart disease, lung disease, blood disease, brain disease, etc.) 20.Patients with uncontrolled adrenal insufficiency, Grade 2 or higher hearing impairment, or Grade 2 or higher neuropathy 21.Patients with hypervitaminosis A 22.Lactating female patients (excluding those who agreed to discontinue breastfeeding during the study period and for 6 months after the final dose of A M80) 23.Female patients who are pregnant or have positive pregnancy test results (female patients who have had a period within 12 months prior to enrollment and may be pregnant will be subjected to a pregnancy test. Female patients who have not had a period within 12 months but whose pregnancy cannot be ruled out due to reasons such as chemical menopause will also be subjected to a pregnancy test) 24.Patients who are otherwise deemed inappropriate for participation in this clinical trial by the principal investigator or sub-investigator","79 Years",{"count":409,"type":20},43,[23],"【Treatment of Urothelial Carcinoma】 Treatment for urothelial carcinoma includes surgery, chemotherapy (anticancer drugs), and radiation therapy. Chemotherapy is generally used when metastasis has already occurred at diagnosis and surgery is not curative (metastatic urothelial carcinoma) or when the cancer recurs after local therapy such as surgery or radiation therapy (recurrent urothelial carcinoma).\n\nAlthough there are several recommended treatments for urothelial carcinoma, the options are often limited by side effects and other factors, and these treatments may not be fully effective. Therefore, the development of safer and more effective treatments is desired.\n\n【About the Drugs to be Used in this Clinical Trial】 In this clinical trial, the investigational drug MIKE-1 will be used in combination with nivolumab plus GC (cisplatin gemcitabine), one of the recommended chemotherapy regimens, and subsequently with nivolumab monotherapy for patients with unresectable metastatic or recurrent urothelial cancer. Nivolumab, cisplatin, and gemcitabine are injectable (intravenous infusion), while MIKE-1 is oral.\n\n【Purpose of the Clinical Trial】 The purpose of this clinical trial is to evaluate the efficacy (how much the cancer shrinks or slows down) and safety of the investigational drug MIKE-1 in combination with nivolumab and gemcitabine and cisplatin therapy in patients with untreated unresectable or recurrent urothelial cancer.",[28,355,413,299],"Urothelial Carcinoma Urethra",[90,415,236,416,417,418],"Gemcitabine, Cisplatin and Nivolumab","renal pelvis cancer","ureteral cancer","urethral cancer","2025-08-09",{"date":421,"type":41},"2025-08-14",{"date":423,"type":41},"2025-05-01",{"date":425,"type":20},"2029-03-01",{"name":427,"class":48},"Nagoya University",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":21,"phases":438,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":75},"100597928","phase-1-a-tumor-immune-biomarker-guided-approach-for-improving-response-to-bcg-in-patients-with-high-risk-nmibc-100597928","NCT07064863","A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.","BCG-TIME","Inclusion Criteria:\n\n* Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).\n* Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.\n* Participants older than 65 years of age.\n\nExclusion Criteria:\n\n* Patients with prior exposure to BCG immunotherapy.\n* Immunosuppressed patients on steroids, transplants etc.",{"count":437,"type":20},31,[61,23],"This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.",[226,229,327,28],[442,226,443,444,445,446,447],"BCG","Gemcitabine","Tumor Immune MicroEnvironment","Systemic immunity","Mucosal immune response","Immune Biomarker","2025-07-14",{"date":450,"type":41},"2025-07-17",{"date":70,"type":20},{"date":453,"type":20},"2027-07-31",{"name":455,"class":48},"Queen's University",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":463,"targetDuration":465,"studyType":350,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":175,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":4},"100585405","jam3-as-a-prognostic-biomarker-in-muscle-invasive-urothelial-carcinoma-correlation-with-therapeutic-response-and-survival-outcomes-100585405","NCT06901934","JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response, and Survival Outcomes","JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response and Survival Outcomes","Inclusion criteria\n\n1. Patients above 18 years\n2. Histopathological confirmed TCC\n3. Patients with MIBC\n4. Patients eligible for neoadjuvant chemotherapy\n\nExclusion criteria\n\n1. Patients with metastatic disease\n2. Patients ineligible for systemic therapy",{"count":464,"type":20},40,"2 Years","Bladder cancer(BC) is the 10th most common cancer globally, with a higher incidence in males than females, being the 6th most common cancer in men with high mortality, causing a societal burden worldwide.\n\nKnown risk factors include age, gender, cigarettes, genetic factors, and other environmental influences .\n\nBC can be classified into non-muscle-invasive BC (NMIBC) and muscle-invasive BC (MIBC) . MIBC exhibits a more aggressive nature, correlates with a higher level of T-stage, and has more significant genetic heterogeneity .\n\nDespite comprehensive treatment regimens comprising neoadjuvant chemotherapy, radical cystectomy (RC) and adjuvant immunotherapies, a significant proportion of MIBC patients continue to progress to more advanced stages with limited clinical indicators.\n\nUnfortunately, the mechanisms underlying BC initiation, proliferation, and progression remain largely unknown.\n\nThe occurrence of genetic alterations is believed to be closely linked to BC tumorigenesis. Therefore, investigating the genetic alterations might offer opportunities to further understand biological changes in BC .\n\nA key mechanism underlying tumor progression and metastasis is the epithelial-mesenchymal transition (EMT), which is associated with increased invasiveness, chemoresistance, and immune evasion.\n\nEMT is characterized by the downregulation of epithelial markers such as E-cadherin (CDH1) and the upregulation of mesenchymal markers like N-cadherin (CDH2), vimentin, Snail, and ZEB proteins .\n\nEmerging evidence suggests that junctional adhesion molecule 3 (JAM3) plays a role in EMT and cancer progression, with documented involvement in gastric cancer.\n\nHowever, its significance in MIBC remains poorly understood. Investigating JAM3 expression in MIBC may provide novel prognostic insights and help refine patient stratification for NAC and immunotherapy.\n\nAim:\n\nThis study aims to analyze JAM3 expression in transurethral biopsies from MIUC patients and correlate it with:\n\n* Tumor aggressiveness (grading, staging, and histological features).\n* Response to neoadjuvant chemotherapy .\n* Patient survival and disease progression.\n\nThis study will provide a better understanding of JAM3's role in EMT and MIUC progression, offering potential biomarker-driven insights for treatment stratification.\n\nIf JAM3 is validated as a prognostic factor, it could guide personalized therapeutic approaches and optimizing NAC outcomes.",[28],"2025-03-24",{"date":470,"type":41},"2025-03-30",{"date":472,"type":20},"2025-10-01",{"date":474,"type":20},"2028-10-01",{"name":476,"class":48},"Zeinab Yahia Zaki",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":49},"100579371","phase-2-9mw2821--toripalimab-vs-9mw2821-for-1st-line-locally-advanced-or-metastatic-urothelial-carcinoma-100579371","NCT06823427","9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* Voluntary participation\n* Age 18-80\n* ECOG 0-1\n* Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is \\>50%.\n* Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma\n* At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.\n* Life expectancy over 12 weeks\n* Appropriate hematological and organ functions\n* Agree to contraceptive measures until 180 days after the last dose of study drug administration\n* Able to understand and follow study visits, treatment, laboratory assessment and other procedures\n\nExclusion Criteria:\n\n* Other concurrent malignancy within 3 years prior to randomization\n* Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (\\>10mg\u002Fday prednisolone equivalent) or other immunosuppressive agents.\n* Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization\n* Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.\n* Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.\n* Have received prior treatment with anti-PD-1, anti-PD-L1\u002FPD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.\n* Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.\n* Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study\n* Preexisting grade ≥ 2 neuropathy prior to randomization\n* Other uncontrolled serious illness\n* Brain metastasis or meningeal carcinomatosis\n* HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive\n* Known allergy to the study drug or components of the study drug\n* Drug abuse or psychiatric disorder that would impact study compliance\n* Other circumstances that the PI judges to be not suitable for the study","80 Years",{"count":257,"type":20},[23],"This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.",[489,28,299,355],"Urothelial Carcinoma",[491],"9MW2821","2025-03-20",{"date":494,"type":41},"2025-03-21",{"date":496,"type":41},"2025-01-17",{"date":498,"type":20},"2027-06",{"name":500,"class":211},"Mabwell (Shanghai) Bioscience Co., Ltd."]