[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-urothelial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-urothelial-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635114","acupuncture-and-exercise-for-ev-pembro-induced-peripheral-neuropathy-100635114",false,"NCT07548476","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)","ACE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)\n* Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third cycle\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks\n* Deemed acceptable for exercise by their treating provider\n* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek, as assessed by the Godin Leisure-Time Exercise Questionnaire\n* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments\n* Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)\n* Referrals to physical therapy are allowed during the study if necessary; and\n* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.\n* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin\n\nExclusion Criteria:\n\n* History of peripheral neuropathy prior to EV-Pembro initiation\n* Patients with a pacemaker or other electronically charged medical device; or\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n\nInvestigators will not include the following special populations:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C 18 years)\n* Pregnant women\n* Prisoners","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with metastatic bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).\n\nThe names of the two study groups in this research study are:\n\n* Acupuncture + Virtual Exercise (AVE)\n* Virtual Exercise Only (VE)",[27,28,29,30],"Metastatic Bladder Cancer","Peripheral Neuropathy","Advanced Urothelial Cancer","Metastatic Urothelial Cancer",[32,33,34],"Enfortumab Vedotin-Induced Neuropathy","Pembrolizumab-Induced Neuropathy","mUC","NOT_YET_RECRUITING","2026-04-28",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":21},"2026-10-02",{"date":43,"type":21},"2027-03-02",{"name":45,"class":46},"Dana-Farber Cancer Institute","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100327809","phase-2-study-of-sacituzumab-govitecan-in-participants-with-urothelial-cancer-that-cannot-be-removed-or-has-spread-100327809","NCT03547973","Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced\u002FMetastatic Urothelial Cancer","TROPHY U-01","Key Inclusion Criteria:\n\nInclusion Criteria for All Cohorts:\n\n* Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).\n* Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.\n* Adequate renal and hepatic function.\n* Adequate hematologic parameters without transfusional support.\n* Individuals must have a 3-month life expectancy.\n\nAdditional Inclusion Criteria for Cohorts 1 to 6:\n\n* Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):\n\n  1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;\n  2. Or received neo\u002Fadjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence\u002Fprogression ≤12 months following completion of therapy.\n* Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)\u002F Anti-programmed Death Ligand 1 (PD-L1) therapy.\n* Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1\u002FPD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease.\n* Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.\n* Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL\u002Fmin calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg\u002Fm\\^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL\u002Fmin calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL\u002Fmin are to receive a split dose of cisplatin (35 mg\u002Fm\\^2 Day 1 and Day 8 of every 21-day cycle).\n* Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.\n* Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after \\> 12 months from completion of therapy.\n* No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).\n* Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.\n* Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or \\>12 months from completion of adjuvant therapy are permitted.\n* Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL\u002Fmin as calculated by the Cockcroft-Gault formula unless otherwise specified\n\nAdditional Inclusion Criteria for Cohort 7:\n\n* No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is \\> 12 months since the last dose of systemic therapy.\n* Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.\n* Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nKey Exclusion Criteria:\n\nExclusion Criteria for All cohorts:\n\n* Females who are pregnant or lactating.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has an active second malignancy.\n* Has known active Hepatitis B or Hepatitis C.\n* Has other concurrent medical or psychiatric conditions.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has an active second malignancy.\n\nAdditional Exclusion Criteria for Cohorts 1 to 6:\n\n* For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade \\\u003C\\\u003C 2 adverse events not constituting a safety risk based on the investigator's judgment are acceptable.\n* Cohort 3: Has received anti-PD-1\u002FPD-L1 therapy previously.\n* Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose of study drug(s), has history or evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.\n* Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant\u002Fadjuvant setting.\n* Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free interval \\>12 months between the last treatment administration and the date of recurrence is required.\n\nAdditional Exclusion Criteria for Cohort 7:\n\n* Have had a prior anticancer therapy within 12 months prior to C1D1 or prior radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of investigational product.\n* Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Have a Child-Pugh score of B or C.\n* Individuals with uncontrolled diabetes.\n* Have active keratitis or corneal ulcerations.\n* Participants with ongoing sensory or motor neuropathy Grade ≥ 2.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":57,"type":21},827,[59],"PHASE2","The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).",[30],"RECRUITING","2026-03-12",{"date":65,"type":39},"2026-03-16",{"date":67,"type":39},"2018-08-13",{"date":69,"type":21},"2030-04",{"name":71,"class":72},"Gilead Sciences","INDUSTRY",135,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":47},"100595561","phase-1-clofarabine-therapy-in-locally-advanced-or-metastatic-urothelial-carcinoma-100595561","NCT07034053","Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma","Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1\u002F2 Dose-Escalation Study","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease\n* Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) greater than or equal to 1500.\n* White blood cell (WBC) count greater than 3.0.\n* Platelets greater than or equal to 100.\n* Hemoglobin greater than 9.0 g\u002FdL.\n* Adequate hepatobiliary function as indicated by the following laboratory values: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Adequate renal function as indicated by the following laboratory values: Serum creatinine ≤ 1.0 mg\u002FdL; if serum creatinine \\> 1.0 mg\u002FdL, then the estimated glomerular filtration rate (GFR) must be \\> 60 mL\u002Fmin\u002F1.73 m\\^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation\n* Adequate cardiac function (NYHA cardiac III-IV excluded)\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Received previous treatment with clofarabine\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy\n* Prior radiation therapy to the pelvis\n* Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days\n* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. In particular: a) New York Heart Association classification stage II, III, or IV congestive heart failure; b) Coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infraction) within 3 months of first dose of study drug; c) Any other primary cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.\n* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).\n* Any medical condition that requires chronic use of oral high-dose corticosteroids (in excess of 1 mg\u002Fkg\u002Fday) (low-dose corticosteroid for pre-medication purposes are allowed).\n* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results\n* Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed\n* Had currently active gastrointestinal disease, or prior surgery that might affect the ability of the participants to absorb oral Clofarabine.\n* Had prior treatment with a known nephrotoxic drug within 2 weeks of the first dose of study drug, unless the participants had a calculated GFR \\>30 at 2 time points no \\\u003C7 days apart during the 2- week period prior to the first dose of study drug.\n* Positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.",{"count":20,"type":21},[83,59],"PHASE1","This phase 1\u002F2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.",[86,30],"Advanced Urothelial Carcinoma","2025-06-23",{"date":89,"type":39},"2025-06-26",{"date":91,"type":39},"2023-10-24",{"date":93,"type":21},"2028-11",{"name":95,"class":46},"Ekaterina Laukhtina"]