{"entity":{"id":"sunrise-1","kind":"trial","name":"SunRISe-1","aka":[],"tldr":"A tiny pretzel-shaped device that slowly releases chemotherapy inside the bladder cleared carcinoma in situ in over 80% of patients whose BCG had failed.","summary":"Cohort 2 (TAR-200 alone): confirmed CR 82%; 51% remained in CR at 1 year; 98% of responses within 12 weeks. FDA approval of Inlexzo (gemcitabine intravesical system) on 9 September 2025 for BCG-unresponsive NMIBC with CIS. Cetrelimab added little. Phase 3 SunRISe-3 (BCG-naive) and SunRISe-4 (MIBC) ongoing.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04640623","url":"https://clinicaltrials.gov/study/NCT04640623"},{"label":"FDA approval of Inlexzo","url":"https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated"}],"tags":[],"related":[],"cancers":["urothelial"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":["tar-200"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":[],"people":["andrea-necchi"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04640623","phase":"2","setting":"BCG-unresponsive high-risk NMIBC with carcinoma in situ: TAR-200 (gemcitabine intravesical system) ± cetrelimab, single-arm cohorts","sponsor":"Johnson & Johnson","participation":[{"nct":"NCT04640623","source":"https://clinicaltrials.gov/study/NCT04640623","fetchedAt":"2026-10-07T16:53:23.898Z","studySha256":"54b63ecf61f38f069e2bbff571170f4d2dc35ca25ddf87ede04fc55a5ebd5a1e","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":220,"enrolmentType":"ACTUAL","siteCount":144,"recruitingSiteCount":0,"countries":["Australia","Belgium","Canada","France","Germany","Greece","Italy","Japan","Netherlands","Portugal","Russia","South Korea","Spain","Ukraine","United Kingdom","United States"]}],"result":"CR 82%; 51% in CR at 12 months.","started":"2020-12-18","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete response rate (CIS)","primary":true,"unit":"%","arms":[{"name":"TAR-200 monotherapy","n":85,"value":82}]},{"endpoint":"Duration of CR ≥12 months","unit":"%","arms":[{"name":"TAR-200 monotherapy","value":51}]}],"replication":"Single-arm registrational cohort; randomised confirmation in SunRISe-3 pending."},"route":"/trials/sunrise-1/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"}],"technology":[{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"}],"drug":[{"id":"tar-200","kind":"drug","name":"Gemcitabine intravesical system (TAR-200)","route":"/drugs/tar-200/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}],"person":[{"id":"andrea-necchi","kind":"person","name":"Andrea Necchi","route":"/people/andrea-necchi/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}