{"preliminary_commentary":{"by_channel":{"x_thread":22,"podcast":8,"youtube":5},"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\": \"NCT02256436\", \"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":{"generated_at":"2026-11-01T08:37:49.282Z","note":"Automated from the 30 newest of 35 indexed sources (May 2017 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":30,"text":"- Whether PD-L1 can predict pembrolizumab benefit\n- Whether pembrolizumab retreatment is appropriate after prior benefit\n- Which subsequent treatments to consider after pembrolizumab"},"drugs_tested":[["pembrolizumab"]],"indication":"recurrent or progressive metastatic urothelial cancer","name":"KEYNOTE-045","nct_id":"NCT02256436","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-045-nct02256436. 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. 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Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab 200 mg for up to 17 cycles (up to approximately 1 additional year).","label":"Pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2020-10-01","type":"ACTUAL"},"conditions":["Urothelial Cancer"],"enrollment":{"count":542,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"paclitaxel","otherNames":[],"type":"DRUG"},{"name":"vinflunine","otherNames":[],"type":"DRUG"},{"name":"docetaxel","otherNames":[],"type":"DRUG"}],"last_update":"2021-09-20","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2016-09-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"},{"measure":"Overall Survival (OS) - All Participants","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"},{"measure":"PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"},{"measure":"OS - Participants With PD-L1 Positive Tumors","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"},{"measure":"PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"},{"measure":"OS - Participants With Strongly PD-L1 Positive Tumors","timeFrame":"Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)"}],"references":[{"citation":"Giannatempo P, Machiels JP, Sassa N, Arranz JA, Fujii Y, Su WP, Keam B, Culine S, Shen YC, Langa JM, Sarid D, Aarts M, Calabro F, Rosenbaum E, Moreno BH, Bavle A, Xu JZ, Rha SY. Impact of Histology on Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Advanced or Metastatic Urothelial Carcinoma in the Phase 3 KEYNOTE-045 and KEYNOTE-361 Trials. Clin Genitourin Cancer. 2025 Apr;23(2):102273. doi: 10.1016/j.clgc.2024.102273. Epub 2024 Nov 15.","pmid":"40037029","type":"DERIVED"},{"citation":"Balar AV, Castellano DE, Grivas P, Vaughn DJ, Powles T, Vuky J, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Necchi A, Petrylak DP, Plimack ER, Xu JZ, Imai K, Moreno BH, Bellmunt J, de Wit R, O'Donnell PH. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up. Ann Oncol. 2023 Mar;34(3):289-299. doi: 10.1016/j.annonc.2022.11.012. Epub 2022 Dec 6.","pmid":"36494006","type":"DERIVED"},{"citation":"Bellmunt J, de Wit R, Fradet Y, Climent MA, Petrylak DP, Lee JL, Fong L, Necchi A, Sternberg CN, O'Donnell PH, Powles T, Plimack ER, Bajorin DF, Balar AV, Castellano D, Choueiri TK, Culine S, Gerritsen W, Gurney H, Quinn DI, Vuky J, Vogelzang NJ, Cristescu R, Lunceford J, Saadatpour A, Loboda A, Ma J, Rajasagi M, Godwin JL, Homet Moreno B, Grivas P. Putative Biomarkers of Clinical Benefit With Pembrolizumab in Advanced Urothelial Cancer: Results from the KEYNOTE-045 and KEYNOTE-052 Landmark Trials. Clin Cancer Res. 2022 May 13;28(10):2050-2060. doi: 10.1158/1078-0432.CCR-21-3089.","pmid":"35247908","type":"DERIVED"},{"citation":"Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.","pmid":"35101941","type":"DERIVED"},{"citation":"van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.","pmid":"31395089","type":"DERIVED"},{"citation":"Fradet Y, Bellmunt J, Vaughn DJ, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Nam K, Frenkl TL, Perini RF, de Wit R, Bajorin DF. Randomized phase III KEYNOTE-045 trial of pembrolizumab versus paclitaxel, docetaxel, or vinflunine in recurrent advanced urothelial cancer: results of >2 years of follow-up. Ann Oncol. 2019 Jun 1;30(6):970-976. doi: 10.1093/annonc/mdz127.","pmid":"31050707","type":"DERIVED"},{"citation":"Vaughn DJ, Bellmunt J, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Li H, Perini RF, Bajorin DF, de Wit R. Health-Related Quality-of-Life Analysis From KEYNOTE-045: A Phase III Study of Pembrolizumab Versus Chemotherapy for Previously Treated Advanced Urothelial Cancer. J Clin Oncol. 2018 Jun 1;36(16):1579-1587. doi: 10.1200/JCO.2017.76.9562. Epub 2018 Mar 28.","pmid":"29590008","type":"DERIVED"},{"citation":"Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.","pmid":"29562804","type":"DERIVED"},{"citation":"Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, Vogelzang NJ, Climent MA, Petrylak DP, Choueiri TK, Necchi A, Gerritsen W, Gurney H, Quinn DI, Culine S, Sternberg CN, Mai Y, Poehlein CH, Perini RF, Bajorin DF; KEYNOTE-045 Investigators. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med. 2017 Mar 16;376(11):1015-1026. doi: 10.1056/NEJMoa1613683. Epub 2017 Feb 17.","pmid":"28212060","type":"DERIVED"},{"citation":"Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. 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