{"preliminary_commentary":{"by_channel":{"x_thread":9,"bluesky_thread":1},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03661320\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"NCT03661320","nct_id":"NCT03661320","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03661320. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming 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 statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":null,"label":"Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy","type":"ACTIVE_COMPARATOR"},{"description":null,"label":"Arm B: Nivolumab + GC Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["Ono Pharmaceutical Co., Ltd."],"completion_date":{"date":"2026-04-14","type":"ACTUAL"},"conditions":["Urinary Bladder Neoplasms","Muscle-Invasive Bladder Cancer"],"enrollment":{"count":855,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Nivolumab","otherNames":["Opdivo","BMS-936558"],"type":"BIOLOGICAL"},{"name":"Gemcitabine","otherNames":["Chemotherapy"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Chemotherapy"],"type":"DRUG"}],"last_update":"2026-09-10","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2026-02-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pathological Complete Response (pCR) rate, in all randomized participants","timeFrame":"Approximately 43 months"},{"measure":"Event-Free Survival (EFS), in all randomized participants","timeFrame":"Approximately 36 months"}],"references":[{"citation":"Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA. PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy. Eur Urol Oncol. 2024 Aug;7(4):914-922. doi: 10.1016/j.euo.2023.11.022. Epub 2023 Dec 27.","pmid":"38155060","type":"DERIVED"},{"citation":"Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.","pmid":"31823654","type":"DERIVED"}],"start_date":{"date":"2018-11-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT03661320"},"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/nct03661320"}