[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610046":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":39,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":282,"collaborators":25,"id":284,"slug":285,"hasResults":286,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":25,"eligibilityCriteria":290,"healthyVolunteers":286,"sex":291,"minAge":292,"maxAge":25,"enrollmentInfo":293,"targetDuration":25,"studyType":296,"phases":297,"briefSummary":300,"conditions":301,"keywords":25,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":25},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Number of Participants Who Experience a Dose-limiting Toxicity (DLT)","Any of the following toxicities will be considered a DLT:\n\nHematuria leading to clot or obstruction; Grade (Gr) 4 thrombocytopenia; Gr 3 thrombocytopenia associated with clinically significant bleeding; Febrile neutropenia for more than 1 hour; Other Gr ≥3 hematologic toxicity lasting \\>7 days; Nonhematologic AE ≥Gr 3 (with exceptions); ≥Gr 2 pneumonitis\u002F interstitial lung disease; Any ≥Gr 3 nonhematologic laboratory value if clinically significant medical intervention is required, leads to hospitalization, persists for \\>7 days, results in a drug induced liver injury, or elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value \\>8 ×upper limit of normal (ULN) regardless of duration and AST or ALT elevation 5 × to 8 × ULN that persists for greater than 2 weeks; Recurrent Gr 2 AE resulting in \\>2 weeks delay in receiving the next treatment dose; Any intervention-related toxicity that results in study intervention discontinuation; Gr 5 toxicity or AE.","Up to approximately 5 weeks",{"measure":14,"description":15,"timeFrame":16},"Number of Participants Who Experience One or More Adverse Events (AEs)","An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.","Up to approximately 24 months",{"measure":18,"description":15,"timeFrame":19},"Number of Participants Who Discontinue Study Treatment Due to AEs","Up to approximately 12 months",[21],{"measure":22,"description":23,"timeFrame":24},"Complete Response Rate (CRR)","CR is defined as the absence of all of the following as determined by local assessment using urine cytology, cystoscopy, biopsy and radiology assessments as applicable:\n\n* High-risk non-muscle invasive urothelial cancer (UC) (defined as high-grade \\[HG\\] noninvasive papillary \\[Ta\\], carcinoma in situ \\[CIS\\], or any submucosal invasive \\[T1\\] disease of the bladder, urethra, or upper tract \\[ureters, renal pelvis\\])\n* Any muscle invasive tumor (T2) or greater in the bladder, including transurethral prostate stromal invasion of UC, or in the upper tract (ureters, renal pelvis)\n* Metastatic UC, defined as:\n\n  * Regional lymph node metastasis of UC (N1 or greater)\n  * Distant lymph node or visceral metastasis of UC (M1)","Up to approximately 3 months",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"MK-3120","EXPERIMENTAL","Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months.",[38],"Biological: MK-3120",[40],{"type":41,"name":34,"description":42,"armGroupLabels":43,"otherNames":44},"BIOLOGICAL","Intravesical administration at one of three doses per protocol",[34],[45],"SKB410",[47],{"name":48,"affiliation":5,"role":49},"Medical Director","STUDY_DIRECTOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":25,"email":55},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[57,75,88,101,116,131,146,161,175,189,204,219,229,244,257,270],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Michael G Oefelein Clinical Trials ( Site 0005)","RECRUITING","Bakersfield","California","93301","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-119.01871,35.37329,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":25,"email":25},"Study Coordinator","661-310-1063",{"facility":76,"status":59,"city":77,"state":78,"zip":79,"country":63,"countryCode":64,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Rutgers Cancer Institute of New Jersey ( Site 0007)","New Brunswick","New Jersey","08901",{"type":66,"coordinates":81},[82,83],-74.45182,40.48622,{"lat":83,"lon":82},[86],{"name":73,"role":53,"phone":87,"phoneExt":25,"email":25},"732-235-7530",{"facility":89,"status":59,"city":90,"state":91,"zip":92,"country":63,"countryCode":64,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Carolina Urologic Research Center ( Site 0006)","Myrtle Beach","South Carolina","29572",{"type":66,"coordinates":94},[95,96],-78.88669,33.68906,{"lat":96,"lon":95},[99],{"name":73,"role":53,"phone":100,"phoneExt":25,"email":25},"843-449-1010",{"facility":102,"status":59,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Medizinische Universität Wien ( Site 0021)","Vienna","State of Vienna","1090","Austria","AT",{"type":66,"coordinates":109},[110,111],16.37208,48.20849,{"lat":111,"lon":110},[114],{"name":73,"role":53,"phone":115,"phoneExt":25,"email":25},"+4367761942300",{"facility":117,"status":59,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"UZ Gent ( Site 0031)","Ghent","Oost-Vlaanderen","9000","Belgium","BE",{"type":66,"coordinates":124},[125,126],3.71667,51.05,{"lat":126,"lon":125},[129],{"name":73,"role":53,"phone":130,"phoneExt":25,"email":25},"+32 9 332 21 11",{"facility":132,"status":59,"city":133,"state":134,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)","Québec","Quebec","G1J 1Z4","Canada","CA",{"type":66,"coordinates":139},[140,141],-71.21454,46.81228,{"lat":141,"lon":140},[144],{"name":73,"role":53,"phone":145,"phoneExt":25,"email":25},"418-525-4444",{"facility":147,"status":59,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Gustave Roussy ( Site 0041)","Villejuif","Val-de-Marne","94805","France","FR",{"type":66,"coordinates":154},[155,156],2.35992,48.7939,{"lat":156,"lon":155},[159],{"name":73,"role":53,"phone":160,"phoneExt":25,"email":25},"+33142115348",{"facility":162,"status":59,"city":163,"state":25,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"European Interbalkan Medical Center ( Site 0051)","Thessaloniki","570 01","Greece","GR",{"type":66,"coordinates":168},[169,170],22.93493,40.64072,{"lat":170,"lon":169},[173],{"name":73,"role":53,"phone":174,"phoneExt":25,"email":25},"+302310400213",{"facility":176,"status":59,"city":177,"state":25,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Rabin Medical Center ( Site 0062)","Petah Tikva","4941492","Israel","IL",{"type":66,"coordinates":182},[183,184],34.88747,32.08707,{"lat":184,"lon":183},[187],{"name":73,"role":53,"phone":188,"phoneExt":25,"email":25},"+97239377377",{"facility":190,"status":59,"city":191,"state":192,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Centro Ricerche Cliniche di Verona ( Site 0072)","Verona","Veneto","37134","Italy","IT",{"type":66,"coordinates":197},[198,199],10.9938,45.43854,{"lat":199,"lon":198},[202],{"name":73,"role":53,"phone":203,"phoneExt":25,"email":25},"+390458126564",{"facility":205,"status":59,"city":206,"state":207,"zip":208,"country":209,"countryCode":210,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)","Amsterdam","North Holland","1066 CX","Netherlands","NL",{"type":66,"coordinates":212},[213,214],4.88969,52.37403,{"lat":214,"lon":213},[217],{"name":73,"role":53,"phone":218,"phoneExt":25,"email":25},"+31205129111",{"facility":220,"status":59,"city":221,"state":222,"zip":223,"country":224,"countryCode":225,"cosmosGeoPoint":25,"geoPoint":25,"contacts":226},"Akershus Universitetssykehus ( Site 0091)","Lorenskog","Akershus","1478","Norway","NO",[227],{"name":73,"role":53,"phone":228,"phoneExt":25,"email":25},"+4767960000",{"facility":230,"status":59,"city":231,"state":232,"zip":233,"country":234,"countryCode":235,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Hospital Universitario Virgen de la Victoria ( Site 0111)","Málaga","Andalusia","29010","Spain","ES",{"type":66,"coordinates":237},[238,239],-4.42034,36.72016,{"lat":239,"lon":238},[242],{"name":73,"role":53,"phone":243,"phoneExt":25,"email":25},"+34 951 032 095",{"facility":245,"status":59,"city":246,"state":247,"zip":248,"country":234,"countryCode":235,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Hospital Universitario 12 de Octubre ( Site 0112)","Madrid","Madrid, Comunidad de","28041",{"type":66,"coordinates":250},[251,252],-3.70256,40.4165,{"lat":252,"lon":251},[255],{"name":73,"role":53,"phone":256,"phoneExt":25,"email":25},"+34913908121",{"facility":258,"status":59,"city":259,"state":25,"zip":260,"country":261,"countryCode":25,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Ankara University Health Practice and Research Hospitals ( Site 0132)","Ankara","06620","Turkey (Türkiye)",{"type":66,"coordinates":263},[264,265],32.85427,39.91987,{"lat":265,"lon":264},[268],{"name":73,"role":53,"phone":269,"phoneExt":25,"email":25},"+90 312 595 71 12",{"facility":271,"status":59,"city":272,"state":25,"zip":273,"country":261,"countryCode":25,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Koc Universitesi Hastanesi ( Site 0133)","Istanbul","34010",{"type":66,"coordinates":275},[276,277],28.94966,41.01384,{"lat":277,"lon":276},[280],{"name":73,"role":53,"phone":281,"phoneExt":25,"email":25},"+905326761078",{"type":283,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100610046","phase-1-a-clinical-study-of-mk-3120-in-people-with-bladder-cancer-mk-3120-003-100610046",false,"NCT07222488","A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)","Phase 1\u002F2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Has histologically confirmed carcinoma in situ (CIS) +\u002F- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.\n* Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).\n* Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +\u002F- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +\u002F- papillary high-risk NMIBC \\>12 months but ≤24 months after the last BCG dose.\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\n* Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.\n* Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.\n* Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>470 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has active infection requiring systemic therapy.\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, or has current pneumonitis\u002FILD.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","ALL","18 Years",{"count":294,"type":295},45,"ESTIMATED","INTERVENTIONAL",[298,299],"PHASE1","PHASE2","Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.",[302,303],"Bladder Cancer","Urinary Bladder Neoplasms","2026-08-20",{"date":306,"type":307},"2026-08-24","ACTUAL",{"date":309,"type":307},"2025-12-09",{"date":311,"type":295},"2029-02-28",{"name":5,"class":6},16]