[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-bladder-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100549463","phase-1-enfortumab-vedotin-with-radiation-for-locally-advanced-bladder-cancer-consolidate-100549463",false,"NCT06434350","Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included.\n2. Be ≥ 18 years of age on the day of signing informed consent.\n3. ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status.\n4. The participant has the following baseline laboratory data:\n\n   1. Hemoglobin ≥ 9 g\u002FdL\n   2. Platelet count ≥ 100 x 109 g\u002FdL\n   3. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin as estimated per institutional standards (glomerular filtration rate \\[GFR\\] can also be used instead of CrCl)\n   4. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n5. Male participants must consistently use highly effective methods of birth control starting at screening and continue throughout study period and for at least 6 months after radiation completion\n6. Female participants must consistently use highly effective methods of birth control starting at screening and continue throughout the study period and for at least 6 months after radiation completion\n7. Candidate for definitive local therapy to active disease per the discretion of the treating physicians.\n\nExclusion Criteria:\n\n1. Has a diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.\n2. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and\u002For member of the study team.\n3. Distant metastatic disease beyond lymph node metastases, which by the discretion of the treating physician cannot be treated definitively in a radiation field\n4. Has history of prior pelvic radiation therapy\n5. Has ongoing clinically significant toxicity (Grade 2 or higher with exception of alopecia) associated with prior systemic therapy\n6. History of uncontrolled diabetes mellitus within 3 months of enrollment. Uncontrolled diabetes 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.\n7. Has estimated life expectancy of less than 12 weeks\n8. Has preexisting sensory or motor neuropathy Grade ≥ 2\n9. Participants receiving ongoing systemic intravenous antimicrobial treatment for active infection at time of randomization\n10. Participants have a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.\n11. Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.\n12. Has 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 participants with adrenal insufficiency.\n13. Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n14. Has received a prior allogeneic stem cell or solid organ transplant.\n15. Has active tuberculosis As the CORe system in MDACC is set up as a one-step enrollment process, the above inclusion criteria will be assessed prior to CORe enrollment. Following CORe enrollment, the below exclusion criteria will be assessed.\n\n1\\. Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.\n\n* Female participants of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation.\n* Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.","ALL","18 Years",{"count":18,"type":19},41,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.",[26],"Advanced Bladder Cancer","RECRUITING","2026-06-12",{"date":30,"type":31},"2026-06-15","ACTUAL",{"date":33,"type":31},"2024-10-10",{"date":35,"type":19},"2027-09-24",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100619548","phase-3-the-impact-of-time-of-day-administration-of-evp-on-objective-response-rate-in-adults-with-advanced-bladder-cancer-100619548","NCT07346053","The Impact of Time-of-day Administration of EV\u002FP on Objective Response Rate in Adults With Advanced Bladder Cancer","CHRONO-EVP: Time-of-day Dependent Administration of Enfortumab Vedotin and Pembrolizumab (EV\u002FP) in Advanced Bladder Cancer","Chrono-EVP","Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria to be eligible for participation in this trial:\n\n  1. Age 18 or older\n  2. Able to provide informed consent\n  3. Histologically confirmed advanced urothelial cancer\n  4. Eligible for standard-of-care EV\u002FP regimen\n  5. Measurable disease per RECIST 1.1\n  6. ECOG performance status 0-2\n  7. Ability to adhere to scheduled infusion times (Before 11:30 a.m. or after 1:30 pm) Waivers to the inclusion criteria will NOT be allowed.\n\nExclusion Criteria:\n\n* Participants who meet any of following exclusion criteria will not be eligible for participation in this trial:\n\n  1. Non-urothelial histology or mixed histology with predominant non-urothelial components\n  2. Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years\n  3. Inability to comply with protocol-specified infusion timing for at least the first 3 months\n  4. Night shift workers\n  5. Clinical evidence of new or enlarging brain metastasis or carcinomatous meningitis\n  6. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial\n  7. Patients who have traveled across ≥2 time zones within the past 14 days prior to randomization will be excluded, due to potential disruption of circadian rhythms (jet lag), which may affect chronotherapy-related endpoints.\n  8. Patients with a clinically diagnosed sleep disorder, including but not limited to insomnia, obstructive sleep apnea, restless leg syndrome, or circadian rhythm sleep-wake disorders, that is moderate to severe, untreated, or poorly controlled, will be excluded.\n\nWaivers to the exclusion criteria will NOT be allowed.",{"count":49,"type":19},224,[51],"PHASE3","The goal of this clinical trial is to learn if the timing of treatments plays a role in how effective the standard-of-care drugs enfortumab vedotin and pembrolizumab (EV\u002FP) works to treat adults with advanced bladder cancer. The trial will also learn if time-of-day reduces EV\u002FP side-effects.\n\nResearchers will compare EV\u002FP given in the morning (before 11:30am) vs in the afternoon (after 1:30pm), to see if circadian rhythm effects how EV\u002FP works to treat advanced bladder cancer.\n\nParticipants will be randomized in Arm A or Arm B to receive drugs EV\u002FP either in the morning (Arm A) or afternoon (Arm B) as part of their standard-of-care treatment for advanced bladder cancer. Participants will:\n\n* Visit the clinic either in the morning (Arm A) or afternoon (Arm B) to receive EV\u002FP treatment as part of their regular medical care for advanced bladder cancer\n* Frequency of visits will follow standard-of-care guidelines\n* Participants will be followed-up by the study team for up to 24 months.",[26],[55,56,57,58,59,60,61],"time-of-day administration","chronotherapy","advanced bladder cancer","circadian rhythm","enfortumab vedotin and pembrolizumab (EV\u002FP)","urothelial cancer","chronoimmunotherapy","NOT_YET_RECRUITING","2026-01-07",{"date":65,"type":31},"2026-01-16",{"date":67,"type":19},"2026-05",{"date":69,"type":19},"2032-12",{"name":71,"class":38},"Guliz Ozgun",5,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":15,"minAge":16,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100608664","a-clinical-study-on-the-safety-tolerance-and-preliminary-efficacy-of--t-cell-injection-in-the-treatment-of-advanced-bladder-cancer-100608664","NCT07204496","A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced Bladder Cancer","γδ-T-BLADDER","Inclusion Criteria:\n\nThe subject voluntarily participates in this study, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.\n\nAged 18-75 years, regardless of gender.\n\nDiagnosed with primary bladder cancer confirmed by histopathology or clinical diagnostic criteria, clinically assessed as unresectable, and having failed at least two prior lines of standard therapy.\n\nAdequate organ function:\n\n1. Hematologic system (no transfusion or hematopoietic growth factor therapy within 14 days prior to enrollment):\n\n   Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n\n   Platelets (PLT) ≥60×10⁹\u002FL\n\n   Hemoglobin (Hb) ≥90 g\u002FL\n2. Liver function:\n\n   Total bilirubin (TBIL) ≤1.5×ULN\n\n   Alanine aminotransferase (ALT) ≤3×ULN\n\n   Aspartate aminotransferase (AST) ≤3×ULN\n\n   Albumin ≥2.8 g\u002FdL\n3. Coagulation function:\n\n   Activated partial thromboplastin time (APTT) ≤1.5×ULN\n\n   International normalized ratio (INR) or prothrombin time (PT) within normal range\n4. Renal function:\n\n   Serum creatinine ≤1.5×ULN, or\n\n   Creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using Cockcroft-Gault formula; applies only if creatinine \\>1.5×ULN)\n5. Thyroid function:\n\n   Thyroid-stimulating hormone (TSH) ≤1×ULN\n\n   Free triiodothyronine (FT3) ≤1×ULN\n\n   Free thyroxine (FT4) ≤1×ULN\n6. Cardiovascular function:\n\nLeft ventricular ejection fraction (LVEF) ≥50% by echocardiography\n\nAJCC Bladder Cancer Stage III or IV.\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\nAt least one measurable lesion (according to mRECIST criteria).\n\nExpected survival time ≥6 months.\n\nMale subjects with partners of childbearing potential must use reliable and effective contraception from signing the informed consent form until 180 days after the last dose of the study drug. Male subjects with pregnant partners must use condoms and require no additional contraception methods.\n\nExclusion Criteria:\n\nPrior treatments within 28 days before the first dose:\n\n1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy, targeted therapy, local therapy, or traditional Chinese medicine with明确抗肿瘤适应症 (clear antitumor indications).\n2. Major surgical procedures or failure to recover from side effects of such surgeries (excluding minor procedures, e.g., appendectomy, tumor biopsy).\n3. Participation in other interventional drug clinical trials (excluding observational studies or survival follow-up).\n\nFailure to recover from prior antitumor therapy-related toxicities (except alopecia) (i.e., toxicity still \\> Grade 1 or not returned to baseline).\n\nConcurrent or history of other malignancies, except:\n\nCurative basal cell or squamous cell skin cancer\n\nCarcinoma in situ of the cervix\n\nPapillary thyroid carcinoma\n\nDuctal carcinoma in situ of the breast\n\nOther malignancies with disease-free survival \\>5 years\n\nUncontrolled diabetes despite optimal supportive care.\n\nPresence of gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, or hepatorenal syndrome.\n\nHistory or presence of autoimmune diseases (e.g., rheumatoid arthritis).\n\nNeurological diseases, diffuse leptomeningeal disease, or comorbid neurodegenerative disorders.\n\nHistory or planned stem cell or organ transplantation during the study.\n\nAny of the following within 6 months before the first dose:\n\n1. Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, or other clinically significant thromboembolic events.\n2. Unstable angina, myocardial infarction, or symptomatic chronic heart failure.\n3. Ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).\n4. Coronary\u002Fperipheral artery bypass grafting.\n5. Current or history of congestive heart failure (NYHA Class II-IV).\n6. Uncontrolled hypertension despite medication (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg).\n\nActive infections, including:\n\n1. Clinically uncontrolled active infections within 7 days before the first dose (e.g., acute pneumonia, unexplained persistent fever).\n2. Hepatitis B (HBsAg-positive and HBV-DNA \\>1000 IU\u002FmL; HBV carriers must receive antiviral therapy per local guidelines and commit to ongoing treatment during the study).\n3. Hepatitis C (HCV antibody-positive).\n4. HIV or Treponema pallidum (TP) infection.\n\nRequirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants.\n\nPregnancy or lactation.\n\nAny uncontrolled concurrent condition (including psychiatric disorders or substance abuse) deemed by the investigator to compromise subject cooperation or trial participation, or any other reason making the subject unsuitable for the study.",true,"75 Years",{"count":83,"type":19},20,"OBSERVATIONAL","We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Through real-world clinical data, we aim to scientifically determine whether this novel T-cell therapy can significantly alter the pathological progression of tumors and improve patient outcomes. Ultimately, we seek to benefit a broader patient population by achieving long-term tumor-bearing or tumor-free survival, transforming cancer management into a chronic disease model and improving patients' quality of life.",[26],"2025-09-24",{"date":89,"type":31},"2025-10-02",{"date":91,"type":19},"2025-09-26",{"date":93,"type":19},"2026-12-31",{"name":95,"class":38},"Shanghai 10th People's Hospital"]