{"entity":{"id":"hr-nmibc","kind":"trial","name":"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)","aka":["SunRISe-3"],"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 or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC) is a phase 3 interventional study registered as NCT05714202, led by Janssen Research & Development, and active but no longer recruiting on the registry. Official title: A Phase 3, Open-Label, Multi-Center, Randomised Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer. Planned enrolment is 1135 participants (actual). The study started in 2023-03-23 and primary completion is expected in 2029-09-18. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05714202","url":"https://clinicaltrials.gov/study/NCT05714202"}],"tags":["ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["cetrelimab"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05714202","phase":"3","setting":"A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer","sponsor":"Janssen Research & Development","started":"2023-03-23","startedType":"actual","enrolled":1135,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/hr-nmibc/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-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/"}]}}