{"commentary":{"count":61,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":23,"x_thread":19,"podcast":17,"x_video":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03635567\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT03635567","nct_id":"NCT03635567","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03635567. The price is fixed at order. 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":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\\^2 PLUS cisplatin 50 mg/m\\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.","label":"Pembrolizumab+Chemotherapy","type":"EXPERIMENTAL"},{"description":"On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\\^2 PLUS cisplatin 50 mg/m\\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.","label":"Placebo+Chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2024-06-04","type":"ACTUAL"},"conditions":["Cervical Cancer"],"enrollment":{"count":617,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Bevacizumab","type":"BIOLOGICAL"},{"name":"Placebo to pembrolizumab","type":"DRUG"}],"last_update":"2026-02-04","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-10-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1","timeFrame":"Up to approximately 46 months"},{"measure":"PFS Per RECIST 1.1 as Assessed by Investigator in All Participants","timeFrame":"Up to approximately 46 months"},{"measure":"PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10","timeFrame":"Up to approximately 46 months"},{"measure":"Overall Survival (OS) in Participants With PD-L1 CPS ≥1","timeFrame":"Up to approximately 46 months"},{"measure":"OS in All Participants","timeFrame":"Up to approximately 46 months"},{"measure":"OS in Participants With PD-L1 CPS ≥10","timeFrame":"Up to approximately 46 months"}],"references":[{"citation":"Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.","pmid":"37910822","type":"RESULT"},{"citation":"Hasegawa K, Colombo N, Tewari KS, Dubot C, Caceres MV, Lorusso D, Shapira-Frommer R, Salman P, Yanez E, Gumus M, de Mendoza MOH, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Jensen E, Toker S, Monk BJ. Pembrolizumab Plus Chemotherapy for Cervical Cancer: An Exploratory Analysis of the KEYNOTE-826 Randomized Clinical Trial. JAMA Oncol. 2026 Sep 10:e263547. doi: 10.1001/jamaoncol.2026.3547. Online ahead of print.","pmid":"42720936","type":"DERIVED"},{"citation":"Kim YM, Nishio S, Kim SI, Hasegawa K, Dubot C, Caceres MV, Tewari KS, Lorusso D, Lee JW, Liou WS, Li K, Tekin C, Colombo N, Monk BJ. Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis. J Gynecol Oncol. 2025 Jul;36(4):e110. doi: 10.3802/jgo.2025.36.e110.","pmid":"40590325","type":"DERIVED"},{"citation":"Monk BJ, van Mens S, Hale O, Boer J, van Hees F, Swami S, Muston D, Tekin C, Keefe S, Monberg M. Cost-Effectiveness of Pembrolizumab as First-Line Treatment in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer in the United States. Oncol Ther. 2025 Mar;13(1):85-98. doi: 10.1007/s40487-024-00311-5. Epub 2024 Nov 5.","pmid":"39499492","type":"DERIVED"},{"citation":"Lorusso D, Colombo N, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera M, Samouelian V, Castonguay V, Arkhipov A, Li K, Toker S, Tekin C, Tewari KS, Monk BJ. Pembrolizumab plus chemotherapy for advanced and recurrent cervical cancer: final analysis according to bevacizumab use in the randomized KEYNOTE-826 study. Ann Oncol. 2025 Jan;36(1):65-75. doi: 10.1016/j.annonc.2024.10.002. Epub 2024 Oct 10.","pmid":"39393777","type":"DERIVED"},{"citation":"Tewari KS, Colombo N, Monk BJ, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Toker S, Keefe SM, Lorusso D. Pembrolizumab or Placebo Plus Chemotherapy With or Without Bevacizumab for Persistent, Recurrent, or Metastatic Cervical Cancer: Subgroup Analyses From the KEYNOTE-826 Randomized Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):185-192. doi: 10.1001/jamaoncol.2023.5410.","pmid":"38095881","type":"DERIVED"},{"citation":"Monk BJ, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Hurtado de Mendoza MO, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Martin Nguyen A, Monberg MJ, Colombo N, Lorusso D. Health-related quality of life with pembrolizumab or placebo plus chemotherapy with or without bevacizumab for persistent, recurrent, or metastatic cervical cancer (KEYNOTE-826): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Apr;24(4):392-402. doi: 10.1016/S1470-2045(23)00052-9. Epub 2023 Mar 3.","pmid":"36878237","type":"DERIVED"},{"citation":"Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.","pmid":"34534429","type":"DERIVED"}],"start_date":{"date":"2018-10-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)","url":"https://clinicaltrials.gov/study/NCT03635567"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03635567"}