{"preliminary_commentary":{"by_channel":{"podcast":4,"youtube":2,"x_thread":2},"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\": \"NCT02538666\", \"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":"CheckMate 451","nct_id":"NCT02538666","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=checkmate-451-nct02538666. 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":"CheckMate 451","arms":[{"description":"Nivolumab intravenous fusion","label":"Nivolumab monotherapy","type":"EXPERIMENTAL"},{"description":"Nivolumab and ipilimumab intravenous fusion","label":"Nivolumab and ipilimumab combination therapy","type":"EXPERIMENTAL"},{"description":"Placebo","label":"Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":["Ono Pharmaceutical Co., Ltd."],"completion_date":{"date":"2021-11-11","type":"ACTUAL"},"conditions":["Lung Cancer"],"enrollment":{"count":907,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":["Opdivo"],"type":"BIOLOGICAL"},{"name":"Ipilimumab","otherNames":["Yervoy"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":[],"type":"OTHER"}],"last_update":"2023-01-05","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2018-10-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population","timeFrame":"From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)"}],"references":[{"citation":"Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.","pmid":"35383114","type":"DERIVED"},{"citation":"Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodriguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. doi: 10.1200/JCO.20.02212. Epub 2021 Mar 8.","pmid":"33683919","type":"DERIVED"}],"start_date":{"date":"2015-10-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy","url":"https://clinicaltrials.gov/study/NCT02538666"},"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/checkmate-451-nct02538666"}