[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-invasive-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-invasive-bladder-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,76,102,124,152,196,222,246,269,297,317,342,371],{"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":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629525","phase-2-a-study-to-find-out-if-enfortumab-vedotin-given-with-pembrolizumab-helps-people-with-muscle-invasive-bladder-cancer-keep-their-bladder-100629525",false,"NCT07475806","A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder","An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)","Inclusion Criteria:\n\n* Participant has histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0. NOTE: urothelial carcinomas (UCs) not originating from the bladder (e.g., upper tract \\[ureters, renal pelvis\\], urethra) are not eligible. UCs invading into the prostatic stroma with no histologic muscle invasion is allowed, provided that the extent of disease is confirmed via imaging.\n* Participant has predominant UC histology (≥ 50%). NOTE: Participants with mixed histology are eligible provided the urothelial component is ≥ 50% (participants whose tumors contain predominant \\[≥ 50%\\] plasmacytoid variant are not eligible). Participants whose tumors contain any neuroendocrine histology are not eligible.\n* Participant is deemed eligible for radical cystectomy and pelvic lymph node dissection.\n* Participant has accessible archival tumor tissue from the primary tumor, for which source and availability have been confirmed prior to study intervention. If no archival tumor tissue is available, the participant will have a biopsy to obtain tumor tissue prior to study intervention.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have a transurethral resection of a bladder tumor within 60 days (+14 days) prior to screening (from the date of informed consent form signature).\n\nExclusion Criteria:\n\n* Participant has preexisting sensory or motor neuropathy Grade ≥ 2.\n* Participant has ≥ N2 disease or metastatic disease (M1) as identified by imaging\n* Participant has a history of uncontrolled diabetes mellitus within 3 months prior to screening. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7% and \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility.\n* Participant has a second malignancy diagnosed within 3 years before first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.\n* Participant has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n* Participant has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.\n* Participant has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n  * 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  * Brief (\\\u003C 7 days) use of systemic corticosteroids is allowed when use is considered standard of care.\n  * Participant with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded.\n  * Participant requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.\n  * Participant with hypothyroidism that is stable with hormone replacement therapy or Sjögren's syndrome will not be excluded.\n* Participant has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n* Participant has received prior systemic anti-cancer therapy for MIBC\u002Fnon-muscle invasive bladder cancer (NMIBC), or received prior systemic anti-cancer therapy including investigational agents (including enfortumab vedotin or other monomethyl auristatin E-based antibody-drug conjugates) within 3 years prior to screening.\n\nNOTE: Prior treatment for NMIBC with intravesical instillation therapy such as Bacillus Calmette-Guérin or intravesical chemotherapy is permitted. Prior systemic treatment (including, but not limited to, anti-PD-1\u002FPD-L1 treatment with pembrolizumab, etc.) received for NMIBC is not permitted.\n\n* Participant has received a partial cystectomy of the bladder to remove any NMIBC or MIBC.\n* Participant has received any prior radiotherapy to the bladder.","ALL","18 Years",{"count":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","People with a type of bladder cancer called muscle-invasive bladder cancer have cancer that has spread into the muscle wall of the bladder. The standard treatment is to have chemotherapy, followed by surgery to completely remove the bladder. This has a significant impact on people with long-term life-altering changes. There are also limited options for people who cannot have chemotherapy or who do not want their bladder removed.\n\nStudies show that enfortumab vedotin, when given with pembrolizumab, can help people with advanced bladder cancer. This treatment has also worked well for people with muscle-invasive bladder cancer who can't receive chemotherapy when it was given before and after bladder-removal surgery. However, some people can't have or won't have this surgery. There is still a need for new treatments that let people keep their bladder. This is especially important for people who respond well to the enfortumab vedotin, when given with pembrolizumab, and may benefit from continuing this study treatment instead of having surgery.\n\nThe main aims of this study are to check how many people continue to respond well to enfortumab vedotin with pembrolizumab and how many people have their bladder intact after 2 years.\n\nPeople in this study will be adults who have muscle-invasive bladder cancer and are able to have surgery to remove the bladder.\n\nPeople cannot take part if they have nerve damage (sensory or motor neuropathy), have had certain other cancers, have diabetes that is not under control, or have had a transplant.\n\nPeople will receive infusions of enfortumab vedotin on the 1st and 8th day of 3-week (21-day) cycles. They will also receive pembrolizumab on the 1st day of every 3-week cycle. There will be safety checks at each visit with checks of the tumors at some visits. The doctors will continue to check for medical problems throughout the study.\n\nPeople will continue to receive study treatment unless their cancer doesn't improve after 9 cycles of study treatment, or until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away.\n\nPeople's whose cancer gets worse or doesn't improve after 9 cycles may need bladder surgery, radiotherapy or chemotherapy. People will visit the clinic after they stop their study treatment, in which they will be asked about any medical problems and have a health check. After this, people will continue to have scans every 12 weeks (3 months) for the first 2 years until their cancer gets worse. After this, if their cancer doesn't get worse, they will continue to have scans every 24 weeks (6 months) for up to 5 years to check for any changes in their cancer. After people's cancer gets worse, they won't have any more scans but will have telephone health checks every 3 months.",[26],"Muscle-invasive Bladder Cancer",[28,29,30,31,32],"ASG-22CE","Enfortumab Vedotin","Bladder Preservation","Pembrolizumab","PADCEV","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2026-03-12",{"date":41,"type":20},"2031-04-30",{"name":43,"class":44},"Astellas Pharma Global Development, Inc.","INDUSTRY",10,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100568553","phase-2-adjuvant-sacituzumab-govitecan-and-nivolumab-in-muscle-invasive-urothelial-carcinoma-at-high-risk-recurrence-100568553","NCT06682728","Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence","Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of study consent.\n* ECOG Performance Status of 0, 1 or 2 (see Appendix A).\n* Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed.\n* Underwent curative-intent surgery (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation.\n* Radiographic disease-free status as determined by imaging within 28 days of C1D1 of study treatment.\n* Prior platinum-based NAC is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \\[10\\]) or refuse platinum AC.\n* Prior treatment with neoadjuvant investigational agents is allowed (except PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan). No washout from neoadjuvant therapy is required.\n* If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on RC or nephroureterectomy surgical spec-imen.\n* If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on RC or nephroureterectomy surgical speci-men.\n* Adequate organ and marrow function as defined below:\n* ANC ≥ 1000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease)\n* AST\u002FALT ≤ 3 × institutional ULN\n* Alkaline phosphatase ≤ 3 × institutional ULN\n* Serum albumin ≥ 2.8 g\u002FdL\n* Creatinine Creatinine clearance of ≥30 mL\u002Fmin (calculated with Cockroft-Gault formula)\n* Hemoglobin ≥ 9.0 g\u002FdL\n* aPTT ≤ 1.5 × institutional ULN\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including male condom, female condom, or diaphragm with spermicidal gel, etc.) that are approved by the Investigator. Contra-ception must be used during the course of the treatment and for 6 months after the last dose of study treatment.\n* Female subjects of childbearing potential must not be pregnant following signing the study consent form. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal sta-tus (defined as at least 12 months of amenorrhea in a woman ≥ 45 years-of-age in the ab-sence of other biological or physiological causes).\n* Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless the AE(s) is clinically non-significant and\u002For stable on supportive therapy as per discretion of the Investigator.\n* Subjects with any type of genitourinary catheters (i.e. nephrostomy, Foley, etc) are al-lowed.\n* Ability to understand and the willingness to sign a written informed consent. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, hard of hearing, and illiterate individuals are eligible for this trial.\n\nExclusion Criteria\n\n* Underwent a partial cystectomy or partial nephrectomy.\n* History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, following surgical removal of UC.\n* History of treatment with PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan prior to study treatment initiation.\n* History of previous radiation therapy for treatment of UC.\n* Radiographic evidence of metastasis.\n* Receipt of or planning to receive any other concurrent investigational agents.\n* History of active, known, or suspected autoimmune disease.\n* Conditions requiring treatment with either systemic high-dose corticosteroids (e.g. prednisone dose of ≥ 10 mg or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.\n* Inhaled or topical steroids are permitted in the absence of active autoimmune dis-ease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Major surgery within 28 days or minor surgery within 14 days before the first dose of study treatment. Subjects must have complete wound healing and resolution from complications of major or minor surgery before first dose of study treatment.\n* Active malignancy within 3 years of study entry, except treated localized non-melanoma skin cancer, Gleason 6 prostate cancer on active surveillance, or curatively treated in situ cancer of the breast or cervix.\n* Patients who do not have adequate organ and marrow function, as defined in Section 4.1 above.\n* Uncontrolled intercurrent illness including, but not limited to, the following conditions:\n* Active and\u002For uncontrolled bacterial, viral, or fungal infection within 7 days of study treatment initiation.\n* History of HIV infection with detectable viral load.\n* History of Hepatitis B or C infection with detectable viral load.\n* History of severe liver impairment (Child-Pugh C liver cirrhosis).\n* History of active tuberculosis (Bacillus tuberculosis).\n* Congestive heart failure New York Heart Association (NYHA) Class 3 or 4, unstable angina pectoris, or serious uncontrolled cardiac arrhythmias.\n* Stroke (including transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic arterial event within 90 days before first dose of study treatment.\n* Severe, uncontrolled bleeding within 14 days before first dose of study treatment.\n* Uncontrolled diarrheal illness ≥ Grade 3 in severity within 14 days before first dose of study treatment.\n* History of inflammatory bowel disease (i.e. ulcerative colitis, Crohn's disease, etc.) or any other condition that puts patients at high risk of developing severe diarrhea.\n* Psychiatric illness\u002Fsocial situations causing inability to comply with study proce-dures or follow up.\n* Pregnancy at the time of or following study consent.\n* Breastfeeding at the time of or following study consent.\n* Received a live vaccine within 28 days prior to the first dose of study treatment.\n* Known or suspected severe hypersensitivity (Grade ≥ 3) to nivolumab, sacituzumab govitecan, irinotecan, and\u002For any of their components.\n* History or current evidence of any condition, therapy, or laboratory\u002Fradiographic abnormal-ity that might confound the results of the study, interfere with the patient's ability to participate for the full duration of the study, or is not in the best interest of the patient to partici-pate in the study, in the opinion of the Investigator.",{"count":54,"type":20},23,[23],"This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.",[58,26],"Urothelial Carcinoma",[60,58,61,62,63,64],"UC","muscle-invasive urothelial carcinoma","MIBC","sacituzumab govitecan","nivolumab","2026-04-28",{"date":67,"type":37},"2026-04-30",{"date":69,"type":37},"2024-11-15",{"date":71,"type":20},"2026-12-01",{"name":73,"class":74},"University of California, Irvine","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":75},"100541884","mpmri-compared-to-diagnostic-turbt-in-patients-with-suspected-muscle-invasive-bladder-cancer-100541884","NCT06335667","mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer","Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study","Inclusion Criteria:\n\n* Age 18 years old or greater at the time of consent.\n* Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.\n* ECOG Performance Status of 0-3.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).\n* Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Prior TURBT within 120 days of study entry.\n* Prior therapy for bladder cancer within 180 days of study entry.\n* Inability to tolerate mpMRI or associated contrast.\n* Inability to tolerate TURBT or associated anesthesia.\n* ECOG Performance Status of 4.\n* Female patient who is known to be pregnant or breastfeeding.",{"count":84,"type":20},30,[86],"NA","This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).",[89,90],"Urothelial Bladder Cancer","Muscle-Invasive Bladder Cancer",[92,93,94],"mpMRI","TURBT","VI-RADS score",{"date":96,"type":37},"2026-05-04",{"date":98,"type":37},"2024-03-27",{"date":100,"type":20},"2030-04",{"name":73,"class":74},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100626843","remodeling-of-mhc-related-immune-microenvironment-in-mibc-after-neoadjuvant-therapy-100626843","NCT07440901","Remodeling of MHC-related Immune Microenvironment in MIBC After Neoadjuvant Therapy","An Exploratory Study on the Remodeling of MHC-related Tumor Immune Microenvironment in Patients With Muscle-invasive Bladder Cancer After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Male or female, aged ≥18 years.\n* Expected survival ≥12 weeks.\n* Diagnosed by histopathology as muscle-invasive bladder urothelial carcinoma (MIBC) without upper urothelial carcinoma.\n* Clinical stage (cT2-T4a, N0-1, M0) and no distant metastasis as evaluated by imaging.\n* The subjects were assessed by urologists as tolerable and planned radical cystectomy.\n* ECOG Physical Condition 0-2.\n\nExclusion Criteria:\n\n* Patients with previous malignant tumors were not eligible to participate in the study unless they had achieved complete remission for at least 5 years prior to enrollment and did not require additional treatment or did not require additional treatment during the study.\n* Combined with serious internal medical diseases including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc.\n* Patients with insufficient communication, understanding and cooperation, or poor compliance, cannot be guaranteed to complete follow-up as required.","75 Years",{"count":84,"type":20},"OBSERVATIONAL","In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored. Meanwhile, the dynamic molecular monitoring of neoadjuvant therapy in MIBC patients and the treatment guidance based on the MHC tumor immune microenvironment were also explored to select the treatment plan based on relevant biomarkers for subsequent immunotherapy in MIBC patients.",[26],"NOT_YET_RECRUITING","2026-02-25",{"date":117,"type":37},"2026-02-27",{"date":119,"type":20},"2026-02-01",{"date":121,"type":20},"2027-05-01",{"name":123,"class":74},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":75},"100593622","radical-cystectomy-or-radio-chemotherapy-as-preferred-treatment-for-invasive-bladder-cancer-100593622","NCT07008833","Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer","Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer","REDEMPTED","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age.\n2. Pure or predominant urothelial carcinoma (including other histologic subtypes, with the exception of small cell carcinoma, as a minority component).\n3. Performance status of 0 to 1, according to the Eastern Cooperative Oncology Group (ECOG) criteria.\n4. Life expectancy of ≥ 3 months.\n5. Histologically confirmed T2, T3, or T4a stage bladder cancer (pure or predominant urothelial carcinoma) cN0 or cN1 or cN2 (if lymph nodes within the surgical and radiation fields and size ≤ 2 cm).\n6. Patients who are candidates for neoadjuvant cisplatin and have undergone TURBT (preferably maximal) prior to treatment.\n7. Adequate bladder function (defined as the ability to store and void urine effectively, without symptoms of dysfunction or incontinence).\n8. Neutrophil count ≥ 1500\u002Fmm³.\n9. Platelet count ≥ 100,000\u002Fmm³.\n10. Hemoglobin count \\> 10 g\u002FdL.\n11. Glomerular filtration rate greater than 40 mL\u002Fmin.\n12. Serum bilirubin \\\u003C 1.5 times the upper limit of the normal reference range and SGOT and SGPT \\\u003C 1.5 times the upper limit of the normal reference range.\n13. Absence of comorbidities that contraindicate treatment.\n14. Capable of giving signed and dated informed consent prior to any mandatory study-specific procedures, sampling, and analyses, which includes compliance with the requirements and restrictions listed in the informed consent form and study protocol.\n15. For inclusion in i) optional exploratory genetic research and ii) optional biomarker research, patients must meet the following criteria:\n\n    * Provide informed consent for genetic research prior to sample collection.\n    * Provide informed consent for biomarker research prior to sample collection.\n    * If a patient declines to participate in optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.\n\nExclusion Criteria:\n\n1. Presence of multiple primary tumors or multiple foci of carcinoma in situ (CIS) (including in the upper tract) that are not candidates for bladder preservation with radiochemotherapy (definition at the discretion of the investigator).\n2. Age \\> 80 years.\n3. Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested.\n4. Metastatic or unresectable disease.\n5. Sensory neuropathy Grade ≥ 2.\n6. Hearing impairment Grade ≥ 2.\n7. Having a known additional malignancy that has progressed or required active treatment in the last 5 years, except superficial bladder cancer and\u002For carcinoma in situ, basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n8. Clinically significant cardiovascular disease - functional class III-IV according to the New York Heart Association (NYHA) Classification of heart failure.\n9. Patients considered to be at high medical risk due to severe and uncontrolled disease, active or non-malignant systemic disease, and severe or potentially severe infection that may affect response to treatment or increase the risk of adverse events.\n10. Immunocompromised patients.\n11. Inflammatory bowel disease.\n12. Patients with known active hepatitis (i.e., hepatitis B or C).\n13. Patients receiving any prior systemic chemotherapy in the last 5 years for other tumors and at any time for muscle-invasive bladder cancer.\n14. Patients who have received prior systemic immunotherapy at any time, either in the setting of non-muscle-invasive bladder cancer or in treatment for other types of cancer.\n15. Prior pelvic radiotherapy.\n16. Patients, male or female, who do not agree to use an effective method of contraception throughout treatment and until 6 months after discontinuation of treatment.\n17. Women who are pregnant or currently breastfeeding. 18. The investigator's judgment that the patient should not participate in the study if the patient is unlikely to comply with the procedures, restrictions, and requirements.\n\n19\\. Prior Randomization to the present study.","80 Years",{"count":134,"type":20},336,[86],"Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:\n\nThis is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments.\n\nThe study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.",[138],"Muscle Invasive Bladder Cancer",[140,141,142],"Bladder cancer","Radiochemotherapy","Radical cystectomy","2026-02-10",{"date":145,"type":37},"2026-02-12",{"date":147,"type":20},"2026-06",{"date":149,"type":20},"2032-02",{"name":151,"class":74},"Brazilian Clinical Research Institute",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":162,"conditions":163,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":75},"100617394","sample-collection-for-ongoing-research-and-product-evaluation-study-100617394","NCT07318051","Sample Collection for Ongoing Research and Product Evaluation Study","Sample Collection for Ongoing Research and Product Evaluation (SCORE) Study","SCORE","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Any patient that has an untreated primary solid malignancy within the following cohorts:\n\n   1. Breast cancer\n   2. Lung cancer\n   3. Muscle invasive bladder cancer\n   4. Rectal cancer\n   5. Pancreatic cancer\n   6. Ovarian cancer\n   7. Gastroesophageal cancer\n   8. Prostate cancer\n   9. Melanoma\n   10. Hepatic\u002Fliver cancer\n   11. Uterine\u002Fendometrial cancer\n   12. Head and neck Cancer\n3. The participant has a suspected primary malignancy of pancreatic, endometrial, bladder, or ovarian cancer based on imaging.\n4. Eastern Cooperative Oncology Group performance status ≤ 2.\n5. Able to tolerate venipuncture for research blood draw(s).\n6. Consent to provide residual tumor tissue for research.\n7. Willing and able to comply with the study requirements.\n8. Signed informed consent(s) must be obtained prior to participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.\n3. Has initiated postoperative systemic treatment.\n4. At time of enrollment, has undergone or plans to undergo any ctDNA testing to assess molecular residual disease, with the exception of comprehensive genomic profiling for therapeutic selection.\n5. History of bone marrow or organ transplant.\n6. Serious medical conditions that may adversely affect ability to participate in the study.",{"count":161,"type":20},9600,"The SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors. The collected specimens and information will be used to evaluate the clinical performance of Natera's molecular residual disease (MRD) testing across multiple cancer types. The study aims to assess the ability of Natera's assays to detect circulating tumor DNA (ctDNA) as a marker for disease recurrence and treatment response.",[164,165,138,166,167,168,169,170,171,172,173,174],"Breast Cancer","Lung Cancer","Rectal Cancer","Pancreatic Cancer","Ovarian Cancer","Gastroesophageal Cancer","Prostate Cancer","Melanoma","Head and Neck Cancer","Uterine Cancer","Liver Cancer",[176,177,178,179,180,181,182,183,171,184,185,186],"Breast cancer","Lung cancer","Muscle invasive bladder cancer","Rectal cancer","Pancreatic cancer","Ovarian cancer","Gastroesophageal cancer","Prostate cancer","Head and Neck cancer","Uterine cancer","Liver cancer","2026-01-13",{"date":189,"type":37},"2026-01-15",{"date":191,"type":37},"2025-07-21",{"date":193,"type":20},"2035-01",{"name":195,"class":44},"Natera, Inc.",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100499159","multi-parametric-mri-in-patients-suspected-for-muscle-invasive-bladder-cancer-a-new-local-staging-paradigm-100499159","NCT05779631","Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm","Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm (BladParadigm)","BladParadigm","Inclusion Criteria:\n\n* Patients (18+ years of age)\n* Clinically suspected MIBC\n* No lymph node or distant metastases\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable or unwilling to undergo mpMRI\n* Unfit for TURBT\n* Unfit for definitive treatment with curative intent\n* A history of cancer, including bladder cancer, except: non-melanoma skin cancer, prostate cancer on active surveillance or a solid malignant tumor ≥5 years disease-free since last treatment",{"count":205,"type":20},360,[86],"A two-arm multicenter randomised controlled trial, comparing progression free survival, time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with suspicion of muscle-invasive bladder cancer.",[209,26],"Bladder Cancer",[211,93],"mpMRI + same-day biopsy","2026-01-05",{"date":214,"type":37},"2026-01-08",{"date":216,"type":37},"2023-12-06",{"date":218,"type":20},"2031-06",{"name":220,"class":74},"Radboud University Medical Center",19,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":54},"100555404","phase-2-erdafitinib-monotherapy-or-in-combination-with-cetrelimab-in-muscle-invasive-bladder-cancer-patients-with-fibroblast-growth-factor-receptor-fgfr--gene-alterations-100555404","NCT06511648","Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations","A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations","SOGUG-NEOWIN","Inclusion Criteria:\n\n1. Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.\n2. Histologically confirmed diagnosis of MIBC (Stage T2-4a N0\u002FN1 M0) obtained via a diagnostic or maximal Transurethral Resection of Bladder Tumor (TURBT) performed no later than 3 months prior to start the screening visit.\n3. Pure or predominant (≥50%) urotelial Cancer (UC) histology as determined at the local site.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n6. Decline or ineligible (\"unfit\") for cisplatin-based chemotherapy\n7. Presence of a selected FGFR alteration on analysis of tumour biopsy\n8. Adequate organ function\n9. No other malignancy\n10. Willingness to avoid pregnancy or fathering children\n\nExclusion Criteria:\n\n1. Clinical evidence of N2-N3 tumours or metastatic bladder cancer.\n2. Has tumour with any neuroendocrine or small cell component.\n3. Patients who are not considered fit for cystectomy or reject cystectomy.\n4. Prior FGFR-targeted or an immune checkpoint inhibitor (antiPD1\u002FPDL1 )systemic therapy.\n5. Prior systemic therapy, radiation therapy, or surgery for bladder cancer",{"count":231,"type":20},90,[23],"Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR )gene alterations and are ineligible for or refuse cisplatin based neoadjuvant chemotherapy.",[26],[236],"Urothelial carcinoma","2025-12-12",{"date":239,"type":37},"2025-12-19",{"date":241,"type":37},"2023-03-07",{"date":243,"type":20},"2029-10",{"name":245,"class":74},"Spanish Oncology Genito-Urinary Group",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100608535","effect-of-neoadjuvant-chemotherapy-on-mri-accuracy-before-cystectomy-100608535","NCT07202819","Effect of Neoadjuvant Chemotherapy on MRI Accuracy Before Cystectomy","Does Neoadjuvant Chemotherapy Affect the Accuracy of Magnetic Resonance Imaging Before Radical Cystectomy? A Randomized Controlled Trial.","\"NAC-MRI\"","Inclusion Criteria:\n\n* Patients diagnosed with cT2 urothelial carcinoma of the urinary bladder, according to the TNM classification, who give informed, written consent on participation in the study and approve all its requirements.\n\nExclusion Criteria:\n\n* Patients who have received pelvic radiotherapy.\n* Previous open or laparoscopic pelvic surgery.\n* Patients with contraindications to MRI.\n* Patients who are unfit for or refuse radical cystectomy.\n* Ineligibility to cisplatin.\n* squamous differentiation in the histopathology",{"count":255,"type":20},76,[86],"The goal of this clinical trial is to learn if neoadjuvant chemotherapy (NAC) affects the accuracy of magnetic resonance imaging (MRI) in staging muscle-invasive bladder cancer (MIBC). This study will also assess how tissue changes induced by NAC impact MRI interpretation. The main questions it aims to answer are:\n\nDoes NAC compromise the accuracy of MRI in staging MIBC?\n\nDoes NAC-induced tissue change affect the reliability of MRI in tumor assessment?\n\nResearchers will compare MRI staging accuracy in MIBC patients who received NAC to those who went directly to surgery, to see if NAC impacts MRI's diagnostic performance.\n\nParticipants will:\n\nUndergo MRI scanning before surgery\n\nReceive either NAC or go directly to surgery, depending on their group assignment\n\nHave their MRI results compared to histopathological outcomes after surgery",[138],"2025-09-24",{"date":261,"type":37},"2025-10-02",{"date":263,"type":37},"2025-09-01",{"date":265,"type":20},"2026-08-20",{"name":267,"class":74},"Assiut University",2,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":278,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":75},"100589680","phase-1-disitamab-vedotin-combined-with-ivonescimab-in-cisplatin-ineligible-muscle-invasive-bladder-cancer-100589680","NCT06957561","Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer","An Open-Label, Single-Arm Phase Ib\u002FII Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Ivonescimab in the Perioperative Treatment of Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (MIBC)","DIVON","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign an informed consent form.\n2. Male or female, aged ≥18 years.\n3. Expected survival ≥12 weeks.\n4. Pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC), with the primary pathological component being urothelial carcinoma ≥50%, and no upper urinary tract urothelial carcinoma.\n5. Clinical staging (cT2-T4a, N0-1, M0) with no distant metastasis as evaluated by imaging.\n6. Based on urologist's assessment, the subject is able to tolerate transurethral resection and radical cystectomy.\n7. No prior immunotherapy, targeted therapy, or biological therapy for MIBC. Cisplatin-ineligible patients may be enrolled.\n8. Cisplatin chemotherapy intolerance\u002Fnon-eligibility (defined as CrCl \\\u003C60 mL\u002Fmin, ≥2-grade hearing impairment, ≥2-grade peripheral neuropathy, ECOG performance status of 2).\n9. Investigator-confirmed HER2 expression: IHC 1+, 2+, or 3+.\n10. ECOG performance status 0-2.\n11. Adequate cardiac, bone marrow, liver, and renal function, with the following parameters meeting the criteria within 7 days prior to the first dose of study drug (normal values based on the clinical trial center):\n\n    * Left ventricular ejection fraction ≥50%;\n    * Hemoglobin ≥9 g\u002FdL;\n    * Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL;\n    * Platelet count ≥90 × 10\\^9\u002FL;\n    * Total bilirubin ≤1.5 times the upper limit of normal (ULN);\n    * ALT and AST ≤2.5 × ULN (ALT, AST ≤5 × ULN for patients with liver metastasis);\n    * Serum creatinine ≤2.0 × ULN or estimated creatinine clearance (CrCl) ≥30 mL\u002Fmin based on the Cockcroft-Gault formula;\n    * Urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1.0g;\n    * International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n12. Female subjects must be surgically sterile, postmenopausal, or agree to use at least one medically accepted form of contraception during the study and for 6 months after the treatment period (e.g., intrauterine device, birth control pills, or condoms). A negative pregnancy test must be confirmed within 7 days prior to study enrollment, and subjects must not be breastfeeding. Male subjects must agree to use at least one medically accepted form of contraception during the study and for 6 months after the treatment period.\n13. Willing and able to comply with the study and follow-up procedures.\n\nExclusion Criteria:\n\n1. Prior systemic antitumor treatment, other than cisplatin, such as targeted therapy, immunotherapy, or biological therapy, before the start of study medication.\n2. Major surgery within 4 weeks prior to the start of study medication.\n3. Positive serum virology tests (based on normal values of the study center):\n\n   * HBsAg or HBcAb positive, with positive HBV DNA copy number.\n   * Positive HCVAb (only if HCV RNA PCR test is negative, the subject may be eligible).\n   * Positive HIVAb.\n4. Receipt of live vaccines within 4 weeks prior to the start of study medication or plans to receive any vaccines during the study (except for the COVID-19 vaccine).\n5. Heart failure classified as NYHA class 3 or higher.\n6. Known central nervous system metastases.\n7. Serious arterial or venous thrombosis, or cardiovascular events such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., within 1 year before the study medication. Excluding asymptomatic lacunar infarctions that do not require clinical intervention.\n8. Active or progressive infections requiring systemic treatment, such as active tuberculosis.\n9. Systemic diseases that are not well controlled, as determined by the investigator, including diabetes, hypertension, liver cirrhosis, interstitial lung disease, obstructive lung disease, etc.\n10. History of serious bleeding disorders or coagulation abnormalities.\n11. History of gastrointestinal perforation or fistula related to anti-VEGF therapy; gastrointestinal perforation, fistula, or intra-abdominal abscess within 3 months before the first dose.\n12. History of esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, fistulas, bowel obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive bowel resection (partial colon resection or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within 6 months before the first dose.\n13. Non-healing or poorly healing wounds, active ulcers.\n14. Imaging or clinical evidence of current gastrointestinal obstruction, including partial obstruction.\n15. Incomplete resolution of prior antitumor treatment toxicity, defined as failure to return to NCI CTCAE v5.0 Grade 0 or 1 toxicity.\n16. Active autoimmune disease requiring systemic treatment (e.g., immunosuppressive agents, corticosteroids, or immunomodulators) prior to the start of study medication. The use of related replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n17. History of any other malignant tumors within the past 5 years, except for the following:\n\n    * Malignant tumors expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).\n18. History of allogeneic hematopoietic stem cell transplant or organ transplant.\n19. Prior treatment with PD-(L)1 inhibitors or other antibody-drug conjugates.\n20. Known allergies to recombinant humanized anti-HER2 monoclonal antibody MMAE conjugates, PD-1\u002FL1 monoclonal antibodies, VEGF antibodies, other monoclonal antibodies, or their components.\n21. Pregnant or breastfeeding women.\n22. Any other disease, metabolic abnormalities, abnormal physical examination, or laboratory findings that, in the investigator's judgment, may indicate a condition that is not suitable for study drug use or may affect the interpretation of study results, or place the patient at high risk.\n23. Estimated non-compliance with the study protocol.",{"count":84,"type":20},[279,23],"PHASE1","This is a single-arm, open-label, Phase Ib\u002FII clinical trial designed to evaluate the efficacy and safety of Disitamab Vedotin combined with Ivonescimab in the perioperative treatment of cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). The study will enroll MIBC patients scheduled for radical cystectomy who have not received prior immunotherapy, targeted therapy, or biological therapy, except for cisplatin chemotherapy. The trial will consist of a neoadjuvant treatment phase (Disitamab Vedotin and Ivonescimab), followed by surgery and an adjuvant treatment phase. Primary efficacy endpoints include the pathological complete response (pCR) rate, while secondary endpoints include disease-free survival, recurrence-free survival, overall survival, and clinical objective response rate. Safety will be monitored throughout the study, and biomarker testing (HER2 and PD-L1) will be conducted to assess treatment efficacy. The study aims to explore the potential of this combination therapy in improving outcomes for MIBC patients.",[209,26],[283,284,285,286,287],"Cisplatin-Ineligible","Muscle-invasive bladder cancer","Disitamab Vedotin","Ivonescimab","Perioperative treatment","2025-04-26",{"date":290,"type":37},"2025-05-04",{"date":292,"type":20},"2025-04-30",{"date":294,"type":20},"2029-05-01",{"name":296,"class":74},"Sun Yat-sen University",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":75},"100586524","phase-1-pilot-study-on-rutin-combined-with-tislelizumab-and-gc-gemcitabine-and-cisplatin-as-neoadjuvant-therapy-for-platinum-refractory-muscle-invasive-bladder-cancer-100586524","NCT06916494","Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer","A Single-Arm, Open-Label, Multicenter Pilot Study：Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n* Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC)\n* No response after 2 cycles of GC neoadjuvant chemotherapy\n* No prior use of systemic immunotherapy or target therapy\n* Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline\n* ECOG (ZPS, 5-point scale) 0-1\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patients with severe cardiac, cerebral, hepatic, or renal disease\n* Severely malnourished patients\n* Patients with mental illness and those without insight and unable to express exactly\n* Combined with malignant tumors of other organs\n* Systemic infectious diseases",{"count":45,"type":20},[279],"This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:\n\n1. Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment.\n2. Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients.\n3. Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.\n\nPatients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.",[138],"2025-04-08",{"date":310,"type":37},"2025-04-10",{"date":312,"type":20},"2025-05-01",{"date":314,"type":20},"2026-01-20",{"name":316,"class":74},"First Affiliated Hospital of Chongqing Medical University",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":75},"100568834","phase-2-tetra-modality-bladder-preservation-strategies-in-muscle-invasive-bladder-cancer-turbt-chemoimmunotherapy-radiation-therapy-maintenance-immunotherapy-vs-ww-100568834","NCT06686381","Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo\u002FImmunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W","A Phase II, Randomized, Non-comparative Double Arm, Open-label, 2-stage, Multicenter Study to Evaluate the Efficacy and Safety of 2 Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer With Maximum TURBT Followed by Induction Platinum-based Chemotherapy\u002FAvelumab Followed by Radiation Therapy Then Maintenance Avelumab or Watch and Wait Approach","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form (ICF) before any trial related procedures.\n2. Male or female participant with ≥ 18 years of age at time of consenting.\n3. Participant is able and willing to comply with the requirements of trial protocol.\n4. Pathologically (histologically or cytologically) and radiologically confirmed newly diagnosed MIBC (T2-T4 N0 M0) or recurrent previously NMIBC.\n5. Histologically confirmed transitional cell carcinoma.\n6. Participant with ECOG Performance Status (PS) ≤ 1 at screening visit.\n7. An estimated life expectancy of more than 6 months.\n8. At screening visit, Left Ventricular Ejection Fraction LVEF \\>50% by echocardiography, for participants planned to receive DDMVAC.\n9. Participant must have adequate laboratory values at screening visit as follow:\n\n   1. Hematologic:\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n      * Platelet count ≥ 100 × 10\\^9\u002FL\n      * Hemoglobin ≥ 9 g\u002FdL (may have been transfused)\n   2. Hepatic:\n\n      * Total bilirubin level ≤ 1.5 × ULN\n      * AST ≤ 2.5 × ULN\n      * ALT ≤ 2.5 × ULN\n   3. Renal:\n\n      * Estimated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft-Gault formula\n      * Serum urea ≤ 1.5 x ULN\n      * Serum creatinine ≤ 1.5 x ULN.\n10. Female participant of childbearing potential must have a negative serum pregnancy test at screening.\n11. For female participant of childbearing potential: use one of the following highly effective contraception methods throughout the trial and for 30 days after the last Avelumab treatment administration.\n\n    * combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation: either oral, intravaginal or transdermal\n    * progesterone-only hormonal contraception associated with inhibition of ovulation: either oral, injectable or implantable\n    * intrauterine device (IUD)\n    * intrauterine hormone-releasing system (IUS)\n    * bilateral tubal occlusion\n    * vasectomised partner (provided that partner is the sole sexual partner of the female trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n    * sexual abstinence\n\nExclusion Criteria:\n\n1. Participant with non-muscle invasive bladder cancer or Metastatic disease (M1) and\u002For lymph node positive.\n2. Participant who underwent radical cystectomy or is planned for radical cystectomy.\n3. Histologically confirmed squamous cell carcinoma, micropapillary carcinoma, neuroendocrine carcinoma, adenocarcinoma, or mixed histology.\n4. Participant had received treatment for urothelial carcinoma, with any of the following anti-cancer therapies prior the first dose of trial treatment: systemic chemotherapy, targeted small molecule therapy, or radiation therapy.\n5. Participant had received prior treatment with any drug or antibody (anti-PD-1, anti-PD- L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody) targeting T-cell co-stimulation or checkpoint pathways.\n6. Participant who are not eligible to receive DDMVAC or Cisplatin-Gemzar.\n7. History of severe hypersensitivity to Avelumab or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI- CTCAE v5.0 Grade ≥ 3).\n8. Participant with hydronephrosis.\n9. Active infection requiring systemic therapy within 28 days before the first dose of trial treatment (e.g., urinary tract infection).\n10. History of testing positive for the human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.\n11. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening visit (positive Hepatitis B surface antigen (HBsAg) or HCV RNA if anti-HCV antibody screening test is positive).\n12. Participant currently using immunosuppressive medication, except for the following:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection).\n    * Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent.\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n13. Active autoimmune diseases that might deteriorate upon receiving an immune- stimulatory agent. Conditions such as vitiligo, psoriasis, diabetes type I, or hypo - or hyper-thyroid diseases not requiring immunosuppressive treatment are eligible.\n14. Participant has any of the following medical conditions: Addison's disease, thyroiditis\u002FHashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, and Grave's disease.\n15. Any psychiatric condition that would prohibit the understanding or rendering of informed consent form.\n16. Hepatic insufficiency manifesting as clinical jaundice, hepatic encephalopathy, and\u002For variceal bleed within 60 days prior to screening.\n17. Clinically significant, active cardiovascular disease, such as:\n\n    * Transmural myocardial infarction within 6 months of enrollment\n    * Unstable angina\n    * Congestive heart failure (New York Heart Association Classification Grade II or greater)\n    * Serious cardiac arrhythmia requiring medical treatment\n18. Cerebral vascular accident\u002F stroke within 6 months of enrollment.\n19. End-stage renal disease requiring dialysis.\n20. Participant has severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior.\n21. Prior organ transplantation including allogenic stem-cell transplantation.\n22. Treatment with an investigational agent within 28 days before the first dose of trial treatment.\n23. Participation in another clinical trial.\n24. Participants who are taking prohibited medication.\n25. Pregnant or breastfeeding women or who are planned to get pregnant or breastfeed during the trial.\n26. Vaccination within 4 weeks of the first dose of Avelumab is prohibited except for administration of inactivated vaccines.\n27. Persisting toxicity related to prior therapy with Grade \\> 1 (NCI-CTCAE v 5.0); with the exception of: alopecia, sensory neuropathy Grade ≤ 2, or other toxicity with Grade ≤ 2 not constituting a safety risk based on investigator's judgment.",{"count":325,"type":20},80,[23],"The purpose of this study is to assess the efficacy and safety of adding the immunotherapy Avelumab as a fourth component, alongside tumor removal, chemotherapy, and radiation, to increase the chance of preserving the bladder in the treatment of muscle-invasive bladder cancer.",[26],[284,330,331,332],"Bladder preservation","Avelumab","Tetramodalities","2025-02-03",{"date":335,"type":37},"2025-02-05",{"date":337,"type":20},"2025-04-15",{"date":339,"type":20},"2028-08-15",{"name":341,"class":74},"American University of Beirut Medical Center",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":75},"100563976","phase-2-sasanlimab-as-maintenance-treatment-based-on-clinical-response-to-neoadjuvant-treatment-in-molecularly-categorized-muscle-invasive-bladder-cancer-patients-100563976","NCT06623162","Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients","Selective Bladder-Sparing Trial with Sasanlimab As Maintenance Treatment Based on Clinical Response to Neoadjuvant Treatment in Molecularly Categorized Muscle Invasive Bladder Cancer Patients","SASAN-SPARING","Inclusion Criteria:\n\n1. Patients who sign a written informed consent approved by an IEC for the participation in this trial.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of ≤ 1 within 28 days prior to registration (Appendix 6).\n4. Histological evidence of localized muscle-invasive urothelial cancer of the bladder (i.e., pT2-T4 \u002F N0 \u002F M0). Candidate for cystectomy as per treating physician.\n5. Absence of metastasis as confirmed by CT or MRI scan of pelvis, abdomen and chest no more than 4 weeks pre-enrolenrment.\n6. Patients candidates to receive neoadjuvant therapy with gemcitabine and cisplatin. Note:MVAC treatment will not be allowed.\n7. All subjects must have adequate archival tissue identified at screening (i.e., at least 15 unstained slides or paraffin block). Subjects without archival tissue must be discussed with the Sponsor-investigator.\n8. Adequate organ and bone marrow function as defined below:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n   2. Hemoglobin (HgB) ≥ 9 g\u002FdL.\n   3. Platelet count ≥ 100 x 10\\^9\u002FL.\n   4. Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula).\n   5. Bilirubin ≤ 1.5 × upper limit of normal (ULN). Note: subjects with Gilbert Syndrome, who have total bilirubin \\< 3.0 mg\u002FdL are eligible.\n   6. Hepatic enzymes Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\< 3 x ULN.\n9. Female patients must either:\n\n   a. Be of nonchildbearing potential: i. Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or ii. Documented surgically sterile (e.g. hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n   * Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects. OR b. If of childbearing potential: i. Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, ii. And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), iii. And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control (Appendix 7) per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.\n10. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n11. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.\n12. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n14. Patient agrees not to participate in another interventional study while on treatment in the present study\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with systemic chemotherapy or other approved anticancer treatments for muscle-invasive urothelial cancer of the bladder. Note: In case of prior non muscle-invasive bladder cancer NMIBC, Mitomycin or Bacillus Calmette Guerin (BCG) treatment are allowed.\n\n  2\\. Another malignancy that is progressing or required active treatment , with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).\n\n  3\\. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Note: Patients with diabetes type I, vitiligo, psoriasis, or hypothyroid or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n\n  4\\. Patients that have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 28 days prior to the first dose of trial treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid).\n\n  5\\. History of allogeneic organ transplant. 6. Active non-infectious pneumonitis, pulmonary fibrosis, or known history of immune mediated pneumonitis.\n\n  7\\. Active infection requiring systemic therapy. Patients with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, or known HIV infection.\n\n  8\\. Live attenuated vaccines within 4 weeks prior to the first dose of sasanlimab and through 30 days following the last dose of sasanlimab are not allowed.\n\nNote: influenza and SARS-CoV-2 vaccines which are inactivated are allowed. 9. Clinically significant cardiovascular diseases, including any of the following:\n\n1. History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to start of study treatment.\n2. Congestive heart failure requiring treatment (New York Heart Association Class ≥2).\n3. Uncontrolled hypertension, defined as persistent systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite optimal therapy.\n4. History or presence of clinically significant or uncontrolled sustained cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).\n5. History of thromboembolic or cerebrovascular events ≤3 months prior to the first dose of study treatment, including ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli. Note: Participants with either deep vein thrombosis or pulmonary emboli that do not result in hemodynamic instability are allowed to enroll as long as they are stable, asymptomatic and on stable anticoagulants for at least 2 weeks. Note: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled. 10. Major surgery less than 28 days prior to the first dose of study treatment. 11. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A \\[IgA\\] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis.\n\n   12\\. Known or suspected hypersensitivity to active ingredients or excipients of the study drug.\n\n   13\\. Pregnant or breastfeeding. 14. Any serious or uncontrolled medical disorder, psychiatric or social condition that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.",{"count":351,"type":20},70,[23],"Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients",[355,138],"Mibc",[62,357,358,359,360,361],"sparing","cystectomy","muscle invasive bladder cancer","gemcitabine","cisplatine","2024-10-02",{"date":364,"type":37},"2024-10-04",{"date":366,"type":20},"2024-12",{"date":368,"type":20},"2027-12",{"name":370,"class":74},"Fundación de investigación HM",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":377,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":75},"100544758","prediction-of-therapeutic-response-to-neoadjuvant-chemotherapy-in-muscle-invasive-bladder-cancer-patients-using-spatial-transcriptomics-100544758","NCT06373055","Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics","Inclusion criteria:\n\n* Suspicious of bladder cancer scheduled to have transurethral resection of bladder tumor\n* Consent to the provision of their biospecimen.\n* Willing to cooperate with this study and comply with the restrictions.\n* Voluntarily signed the consent form for participation in the study.\n* Age ≥18.\n\nExclusion criteria:\n\n* Do not agree with this study.\n* Vulnerable participants",{"count":378,"type":20},250,"Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and\u002For molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection.",[26],"2024-04-15",{"date":383,"type":37},"2024-04-18",{"date":385,"type":20},"2024-05-01",{"date":387,"type":20},"2033-11",{"name":389,"class":74},"Yonsei University"]