{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"SunRISe-1","nct_id":"NCT04640623","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=sunrise-1-nct04640623. The price is quoted from the commentary indexed so far and fixed at order. Final coverage is set when the report is built. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"SunRISe-1","arms":[{"description":"TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).","label":"Cohort 1: TAR-200 and Cetrelimab","type":"EXPERIMENTAL"},{"description":"TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).","label":"Cohort 2: TAR-200","type":"EXPERIMENTAL"},{"description":"Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).","label":"Cohort 3: Cetrelimab","type":"EXPERIMENTAL"},{"description":"TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).","label":"Cohort 4: TAR-200 (Participants with Papillary Disease only)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"conditions":["Urinary Bladder Neoplasms"],"enrollment":{"count":220,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"TAR-200","type":"DRUG"},{"name":"Cetrelimab","type":"BIOLOGICAL"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-07-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate","timeFrame":"From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)"},{"measure":"Cohort 4: Disease-free Survival (DFS)","timeFrame":"From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)"}],"references":[{"citation":"Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Nov 20;43(33):3578-3588. doi: 10.1200/JCO-25-01651. Epub 2025 Jul 30.","pmid":"40737582","type":"DERIVED"}],"start_date":{"date":"2020-12-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy","url":"https://clinicaltrials.gov/study/NCT04640623"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/sunrise-1-nct04640623"}