[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619548":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":32,"responsibleParty":104,"collaborators":108,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":24,"enrollmentInfo":120,"targetDuration":24,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":136,"whyStopped":24,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"British Columbia Cancer Agency","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Morning EV\u002FP Treatment","ACTIVE_COMPARATOR","Participants will receive standard-of-care therapy (Ev\u002FP) administered in the morning (before 11:30am).",[13],"Drug: enfortumab vedotin and pembrolizumab (EV\u002FP)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B: Afternoon EV\u002FP Treatment","Participants will receive standard-of-care therapy (EV\u002FP) administered in the afternoon (after 1:30pm).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","enfortumab vedotin and pembrolizumab (EV\u002FP)","Participants will receive EV\u002FP as part of their standard-of-care therapy administered either in the morning (Arm A) or afternoon (Arm B), as determined by randomization.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Dr. Guliz Ozgun, MD","CONTACT","604-877-6000","676225","guliz.ozgun@bccancer.bc.ca",[33,51,65,79,90],{"facility":34,"status":24,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"BC Cancer - Abbotsford","Abbotsford British Columbia","British Columbia","V2S 0C2","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-122.25257,49.05798,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Dr. Muhammad Zulfiqar, MD","(604) 851-4710","MZulfiqar@bccancer.bc.ca",{"facility":52,"status":24,"city":53,"state":36,"zip":54,"country":38,"countryCode":39,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)","Kelowna","V1Y 5L3",{"type":41,"coordinates":56},[57,58],-119.48568,49.88307,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":24,"email":64},"Dr. Daygen Finch, MD","250-712-3900","DFinch-02@bccancer.bc.ca",{"facility":66,"status":24,"city":67,"state":36,"zip":68,"country":38,"countryCode":39,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"BC Cancer - Surrey","Surrey","V3V 1Z2",{"type":41,"coordinates":70},[71,72],-122.82509,49.10635,{"lat":72,"lon":71},[75],{"name":76,"role":28,"phone":77,"phoneExt":24,"email":78},"Dr. Krista Noonan, MD","604-930-2098","KNoonan2@bccancer.bc.ca",{"facility":80,"status":24,"city":81,"state":36,"zip":82,"country":38,"countryCode":39,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"BC Cancer - Vancouver Cancer Centre","Vancouver","V5Z 4E6",{"type":41,"coordinates":84},[85,86],-123.11934,49.24966,{"lat":86,"lon":85},[89],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"facility":91,"status":24,"city":92,"state":36,"zip":93,"country":38,"countryCode":39,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"BC Cancer - Victoria","Victoria","V8R 6V5",{"type":41,"coordinates":95},[96,97],-123.35155,48.4359,{"lat":97,"lon":96},[100],{"name":101,"role":28,"phone":102,"phoneExt":24,"email":103},"Dr. Richard Gagnon, MD","250-519-5500","Richard.Gagnon@islandhealth.ca",{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Guliz Ozgun","Medical Oncologist, Principal Investigator",[109],{"name":5,"class":6},"100619548","phase-3-the-impact-of-time-of-day-administration-of-evp-on-objective-response-rate-in-adults-with-advanced-bladder-cancer-100619548",false,"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.","ALL","18 Years",{"count":121,"type":122},224,"ESTIMATED","INTERVENTIONAL",[125],"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.",[128],"Advanced Bladder Cancer",[130,131,132,133,21,134,135],"time-of-day administration","chronotherapy","advanced bladder cancer","circadian rhythm","urothelial cancer","chronoimmunotherapy","NOT_YET_RECRUITING","2026-01-07",{"date":139,"type":140},"2026-01-16","ACTUAL",{"date":142,"type":122},"2026-05",{"date":144,"type":122},"2032-12",{"name":106,"class":6},5]