{"preliminary_commentary":{"by_channel":{"x_thread":40,"youtube":33,"podcast":31,"x_video":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02625961\", \"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."},"commentary_summary":null,"name":"KEYNOTE-057","nct_id":"NCT02625961","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-057-nct02625961. 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":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with carcinoma-in-situ (CIS) with or without papillary tumors (Cohort A) and participants with papillary tumors only, without CIS (Cohort B) will receive pembrolizumab, 200 mg, intravenously, every 3 weeks (Q3W) for up to 24 months.","label":"Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants with CIS with or without papillary tumors (Cohort C) will receive either pembrolizumab/vibostolimab or favezelimab/pembrolizumab coformulation intravenously Q3W for up to 24 months","label":"Pembrolizumab coformulation","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-11-05","type":"ACTUAL"},"conditions":["Bladder Cancer"],"enrollment":{"count":296,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA"],"type":"BIOLOGICAL"},{"name":"Pembrolizumab/vibostolimab coformulation","otherNames":["MK-7684A"],"type":"BIOLOGICAL"},{"name":"Favezelimab/pembrolizumab coformulation","otherNames":["MK-4280A"],"type":"BIOLOGICAL"}],"last_update":"2026-08-31","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination With Other Investigational Agents in Subjects With High Risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2025-11-05","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohort A: Complete Response (CR) Rate of High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)","timeFrame":"Up to approximately 6 months"},{"measure":"Cohort B: 12-month Disease-Free Survival (DFS) Rate of High-Risk NMIBC","timeFrame":"Up to approximately 12 months"},{"measure":"Cohort A and B: Number of Participants Who Experience an Adverse Event (AE)","timeFrame":"Up to approximately 27 months"},{"measure":"Cohort A and B: Number of Participants Who Discontinue Study Treatment Due to an AE","timeFrame":"Up to approximately 24 months"}],"references":[{"citation":"Necchi A, Roumiguie M, Kamat AM, Shore ND, Boormans JL, Esen AA, Lebret T, Kandori S, Bajorin DF, Krieger LEM, Niglio SA, Uchio EM, Seo HK, de Wit R, Singer EA, Grivas P, Nishiyama H, Li H, Baranwal P, Van den Sigtenhorst-Fijlstra M, Kapadia E, Kulkarni GS. Pembrolizumab monotherapy for high-risk non-muscle-invasive bladder cancer without carcinoma in situ and unresponsive to BCG (KEYNOTE-057): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2024 Jun;25(6):720-730. doi: 10.1016/S1470-2045(24)00178-5. Epub 2024 May 10.","pmid":"38740030","type":"DERIVED"},{"citation":"Balar AV, Kamat AM, Kulkarni GS, Uchio EM, Boormans JL, Roumiguie M, Krieger LEM, Singer EA, Bajorin DF, Grivas P, Seo HK, Nishiyama H, Konety BR, Li H, Nam K, Kapadia E, Frenkl T, de Wit R. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol. 2021 Jul;22(7):919-930. doi: 10.1016/S1470-2045(21)00147-9. Epub 2021 May 26.","pmid":"34051177","type":"DERIVED"}],"start_date":{"date":"2016-02-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)","url":"https://clinicaltrials.gov/study/NCT02625961"},"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/keynote-057-nct02625961"}