{"entity":{"id":"nct04658862","kind":"trial","name":"A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder","aka":["SunRISe-2"],"tldr":"A phase 3 trial testing Cetrelimab in bladder & urothelial cancer, active and no longer recruiting.","summary":"A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder is a phase 3 interventional study registered as NCT04658862, led by Janssen Research & Development, and active but no longer recruiting on the registry. Official title: A Phase 3, Multi-centre, Randomised Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy. Planned enrolment is 518 participants (actual). The study started in 2020-12-07 and primary completion is expected in 2026-12-30. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04658862","url":"https://clinicaltrials.gov/study/NCT04658862"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetrelimab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04658862","phase":"3","setting":"A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy","sponsor":"Janssen Research & Development","participation":[{"nct":"NCT04658862","source":"https://clinicaltrials.gov/study/NCT04658862","fetchedAt":"2026-10-07T16:53:24.647Z","studySha256":"93984fca3019e143b96111289c3c4c1ba027d4838918b1a0bc96ae0ac6c2f24a","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-09-25","leadSponsor":"Janssen Research & Development, LLC","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":518,"enrolmentType":"ACTUAL","siteCount":290,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","China","Czechia","France","Germany","Greece","Hungary","India","Italy","Japan","Mexico","Poland","Portugal","Russia","South Korea","Spain","Taiwan","Turkey (Türkiye)","Ukraine","United States"]}],"started":"2020-12-07","startedType":"actual","enrolled":518,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04658862/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"drug":[{"id":"cetrelimab","kind":"drug","name":"Cetrelimab","route":"/drugs/cetrelimab/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}]}}