[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636474":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":54,"studyPopulation":45,"armGroups":55,"interventions":74,"overallOfficials":120,"centralContacts":125,"locations":131,"responsibleParty":275,"collaborators":277,"id":279,"slug":280,"hasResults":281,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":45,"eligibilityCriteria":285,"healthyVolunteers":281,"sex":286,"minAge":287,"maxAge":45,"enrollmentInfo":288,"targetDuration":45,"studyType":291,"phases":292,"briefSummary":294,"conditions":295,"keywords":298,"overallStatus":134,"whyStopped":45,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"Bladder-intact Event Free Survival (BI-EFS) by Blinded Independent Central Review (BICR)","BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment confirmed by BICR, histologically confirmed recurrent MIBC by BICR, disease progression by BICR, cystectomy, or death from any cause.","Up to approximately 45.5 months",{"measure":14,"description":15,"timeFrame":16},"Overall Survival (OS)","Time from randomization to death due to any cause.","Up to approximately 60 months",[18,21,24,28,31,34,37,41],{"measure":19,"description":20,"timeFrame":12},"Bladder-intact Event Free Survival (BI-EFS) by Investigator","BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment, histologically confirmed recurrent MIBC, disease progression, cystectomy, or death from any cause.",{"measure":22,"description":23,"timeFrame":16},"Complete clinical response (cCR) rate by Blinded Independent Central Review (BICR) and Investigator","cCR is defined as no radiographic evidence of residual or metastatic disease on imaging, negative cystoscopy, negative pathology except for low-grade Ta, and negative urine cytology.",{"measure":25,"description":26,"timeFrame":27},"Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) and Investigator","Time from randomization to radiologically or pathologically confirmed distant metastasis, or death due to any cause, whichever occurs first.","Up to approximately 60 months]",{"measure":29,"description":30,"timeFrame":16},"Time to Cystectomy","The time from randomization to cystectomy.",{"measure":32,"description":33,"timeFrame":16},"Disease Free Survival (DFS) by Blinded Independent Central Review (BICR) and Investigator","The time from cCR to local recurrence or distant metastases, a second primary bladder cancer, or death due to any cause, whichever occurs first.",{"measure":35,"description":36,"timeFrame":16},"Cystectomy Free Survival (CFS)","The time from randomization to cystectomy or death due to any cause, whichever occurs first.",{"measure":38,"description":39,"timeFrame":40},"Number of Participants with Treatment Emergent Adverse Event (TEAE)","An AE is any untoward medical occurrence in a participant who receives a study treatment without regard to possibility of causal relationship. Treatment-emergent are events between the first dose of study treatment and up to 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state.","From start of study treatment up to 30 days after last dose of study drug (approximately up to 1.1 years)",{"measure":42,"description":43,"timeFrame":44},"Number of Participants with Serious TEAEs","An SAE is any AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability\u002F incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state.","From start of treatment up to 90 days after the last dose of study treatment (approximately up to 1.3 years)",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","A randomized, controlled, parallel-group, multicenter, open-label study of EV in combination with pembrolizumab versus an active comparator-cCRT in adult participants with MIBC who are ineligible for or have elected not to undergo cystectomy. The study is open-label, and the investigators, participants, and sponsor will be aware of the study intervention assignment. The study intervention assignment is by randomization (1:1).","TREATMENT",{"masking":52,"maskingDescription":53,"whoMasked":45},"NONE","Open-label","This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care concurrent chemoradiotherapy, in subjects with previously untreated muscle invasive bladder cancer.\n\nEnfortumab vedotin may be administered for up to 9 cycles or a protocol defined reason for study discontinuation occurs, whichever is first. Pembrolizumab may be administered for a maximum of 17 cycles (3-week cycles) or a protocol-defined reason for study discontinuation occurs, whichever is first. Concurrent chemoradiotherapy may be administered for a maximum of 6.5 weeks.",[56,63],{"label":57,"type":58,"description":59,"interventionNames":60},"Arm A","EXPERIMENTAL","Enfortumab vedotin + pembrolizumab (EV + P)",[61,62],"Drug: Enfortumab vedotin","Drug: Pembrolizumab",{"label":64,"type":65,"description":66,"interventionNames":67},"Arm B","ACTIVE_COMPARATOR","Concurrent Chemoradiotherapy (cCRT)",[68,69,70,71,72,73],"Radiation: Conventional Radiotherapy","Radiation: Hypofractionated Radiotherapy","Drug: Cisplatin","Drug: Fluorouracil","Drug: Mitomycin C","Drug: Gemcitabine",[75,84,89,93,97,104,110,114],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","Enfortumab vedotin","Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9.",[57],[81,82,83],"• Padcev","• ASG-22CE","• ASG-22Me",{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":45},"RADIATION","Conventional Radiotherapy","64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes.",[64],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":45},"Hypofractionated Radiotherapy","55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only.",[64],{"type":76,"name":94,"description":95,"armGroupLabels":96,"otherNames":45},"Cisplatin","40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation.",[64],{"type":76,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Fluorouracil","500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C.",[64],[102,103],"• 5-Fluorouracil","• 5-FU",{"type":76,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Mitomycin C","12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil.",[64],[109],"• MMC",{"type":76,"name":111,"description":112,"armGroupLabels":113,"otherNames":45},"Gemcitabine","100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiation",[64],{"type":76,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"Pembrolizumab","IV infusion on Day 1 of every 3-week cycle up to cycle 17.",[57],[119],"Keytruda",[121],{"name":122,"affiliation":123,"role":124},"Zejing Wang, MD\u002FPhD","Pfizer","STUDY_DIRECTOR",[126],{"name":127,"role":128,"phone":129,"phoneExt":45,"email":130},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[132,146,156,166,176,186,196,206,216,225,235,245,254,264],{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":45},"Samsun Clinic - Ridley-Tree Cancer Center","RECRUITING","Santa Barbara","California","93105","United States","US",{"type":141,"coordinates":142},"Point",[143,144],-119.69819,34.42083,{"lat":144,"lon":143},{"facility":147,"status":134,"city":148,"state":149,"zip":150,"country":138,"countryCode":139,"cosmosGeoPoint":151,"geoPoint":155,"contacts":45},"Rocky Mountain Cancer Center","Aurora","Colorado","80012",{"type":141,"coordinates":152},[153,154],-104.83192,39.72943,{"lat":154,"lon":153},{"facility":157,"status":134,"city":158,"state":159,"zip":160,"country":138,"countryCode":139,"cosmosGeoPoint":161,"geoPoint":165,"contacts":45},"Medical Oncology Hematology Consultants","Newark","Delaware","19713",{"type":141,"coordinates":162},[163,164],-75.74966,39.68372,{"lat":164,"lon":163},{"facility":167,"status":134,"city":168,"state":169,"zip":170,"country":138,"countryCode":139,"cosmosGeoPoint":171,"geoPoint":175,"contacts":45},"Illinois Cancer Specialists","Niles","Illinois","60714",{"type":141,"coordinates":172},[173,174],-87.80284,42.01892,{"lat":174,"lon":173},{"facility":177,"status":134,"city":178,"state":179,"zip":180,"country":138,"countryCode":139,"cosmosGeoPoint":181,"geoPoint":185,"contacts":45},"Fort Wayne Medical Oncology and Hematology","Fort Wayne","Indiana","46825",{"type":141,"coordinates":182},[183,184],-85.12886,41.1306,{"lat":184,"lon":183},{"facility":187,"status":134,"city":188,"state":189,"zip":190,"country":138,"countryCode":139,"cosmosGeoPoint":191,"geoPoint":195,"contacts":45},"Missouri Cancer Associates","Columbia","Missouri","65201",{"type":141,"coordinates":192},[193,194],-92.33407,38.95171,{"lat":194,"lon":193},{"facility":197,"status":134,"city":198,"state":199,"zip":200,"country":138,"countryCode":139,"cosmosGeoPoint":201,"geoPoint":205,"contacts":45},"Oncology Hematology Care Clinical Trials, LLC","Fairfield","Ohio","45014",{"type":141,"coordinates":202},[203,204],-84.5605,39.34589,{"lat":204,"lon":203},{"facility":207,"status":134,"city":208,"state":209,"zip":210,"country":138,"countryCode":139,"cosmosGeoPoint":211,"geoPoint":215,"contacts":45},"Williamette Valley Cancer Institute and Research Center","Eugene","Oregon","97401",{"type":141,"coordinates":212},[213,214],-123.08675,44.05207,{"lat":214,"lon":213},{"facility":217,"status":134,"city":218,"state":209,"zip":219,"country":138,"countryCode":139,"cosmosGeoPoint":220,"geoPoint":224,"contacts":45},"Compass Oncology - West","Tigard","97223",{"type":141,"coordinates":221},[222,223],-122.77149,45.43123,{"lat":223,"lon":222},{"facility":226,"status":134,"city":227,"state":228,"zip":229,"country":138,"countryCode":139,"cosmosGeoPoint":230,"geoPoint":234,"contacts":45},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":141,"coordinates":231},[232,233],-86.78444,36.16589,{"lat":233,"lon":232},{"facility":236,"status":134,"city":237,"state":238,"zip":239,"country":138,"countryCode":139,"cosmosGeoPoint":240,"geoPoint":244,"contacts":45},"Texas Oncology","Austin","Texas","78705",{"type":141,"coordinates":241},[242,243],-97.74306,30.26715,{"lat":243,"lon":242},{"facility":246,"status":134,"city":247,"state":238,"zip":248,"country":138,"countryCode":139,"cosmosGeoPoint":249,"geoPoint":253,"contacts":45},"Texas Oncology - Northeast Texas","Tyler","75702",{"type":141,"coordinates":250},[251,252],-95.30106,32.35126,{"lat":252,"lon":251},{"facility":255,"status":134,"city":256,"state":257,"zip":258,"country":138,"countryCode":139,"cosmosGeoPoint":259,"geoPoint":263,"contacts":45},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"type":141,"coordinates":260},[261,262],-76.28522,36.84681,{"lat":262,"lon":261},{"facility":265,"status":134,"city":266,"state":267,"zip":45,"country":268,"countryCode":269,"cosmosGeoPoint":270,"geoPoint":274,"contacts":45},"Site CA01071","Montreal","Quebec","Canada","CA",{"type":141,"coordinates":271},[272,273],-73.58781,45.50884,{"lat":273,"lon":272},{"type":276,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[278],{"name":123,"class":6},"100636474","phase-3-enfortumab-vedotin-in-combination-with-pembrolizumab-vs-concurrent-chemoradiotherapy-ccrt-in-people-with-muscle-invasive-bladder-cancer-ev-309-100636474",false,"NCT07566156","Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)","A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY","Inclusion Criteria:\n\n* Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0\n* Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline\n* Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens\n* Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta\u002FT1\u002FCIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy\n* Has received any prior systemic treatment, chemoradiation, and\u002For radiation for MIBC or NMIBC\n* Prior pelvic radiation for any reason\n* Inadequate bladder function\n* Other active malignancies within 3 years prior to randomization\n* Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)\n* Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor\n* Uncontrolled diabetes\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection\n* Received major surgery (defined as requiring general anesthesia and \\>24 hour inpatient hospitalization) within 4 weeks prior to randomization\n* Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin\n* Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)\n* Active keratitis or corneal ulcerations\n* History of autoimmune disease that has required systemic treatment in the past 2 years\n* 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* Prior allogeneic stem cell or solid organ transplant\n* Received a live attenuated vaccine within 30 days prior to randomization","ALL","18 Years",{"count":289,"type":290},390,"ESTIMATED","INTERVENTIONAL",[293],"PHASE3","This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.",[296,297],"Urothelial Cancer","Urinary Bladder Neoplasms",[299,300,301,302,303,304,305,306,307,308,309,297,94,98,310,111,311,77,115,296,312,313,314],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy","Complications","Urogenital Diseases","Urinary Bladder Diseases","Urologic Diseases","Male Urogenital Diseases","Mitomycin","Muscle Invasive Bladder Cancer","Urothelial Carcinoma","Bladder-sparing","Bladder Preservation","2026-09-10",{"date":317,"type":318},"2026-09-11","ACTUAL",{"date":320,"type":318},"2026-05-11",{"date":322,"type":290},"2032-02-29",{"name":324,"class":6},"Astellas Pharma Global Development, Inc.",14]