{"preliminary_commentary":{"by_channel":{"x_thread":41,"podcast":21,"youtube":15},"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\": \"NCT03189719\", \"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,"drugs_tested":[["pembrolizumab"]],"indication":"previously untreated advanced or metastatic esophageal cancer","name":"KEYNOTE-590","nct_id":"NCT03189719","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-590-nct03189719. 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 receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","label":"Pembrolizumab + SOC","type":"EXPERIMENTAL"},{"description":"Participants receive placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","label":"Placebo + SOC","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-07-10","type":"ACTUAL"},"conditions":["Esophageal Neoplasms"],"enrollment":{"count":749,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"5-FU","otherNames":[],"type":"DRUG"}],"last_update":"2024-10-15","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-07-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)","timeFrame":"Up to approximately 34 months"},{"measure":"OS in Participants With ESCC","timeFrame":"Up to approximately 34 months"},{"measure":"OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)","timeFrame":"Up to approximately 34 months"},{"measure":"OS in All Participants","timeFrame":"Up to approximately 34 months"},{"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 ESCC","timeFrame":"Up to approximately 34 months"},{"measure":"PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)","timeFrame":"Up to approximately 34 months"},{"measure":"PFS Per RECIST 1.1 As Assessed By Investigator in All Participants","timeFrame":"Up to approximately 34 months"}],"references":[{"citation":"Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Yatsuzuka N, Sakata T, Han S, Doi T. First-line pembrolizumab plus chemotherapy versus chemotherapy alone for advanced esophageal cancer: 5-year extended follow-up in the Japanese subgroup of KEYNOTE-590. Esophagus. 2026 Jul;23(3):486-500. doi: 10.1007/s10388-026-01200-8. Epub 2026 Apr 28.","pmid":"42047965","type":"DERIVED"},{"citation":"Zhang Y, Diez Garcia M, Shah S, Joo S, Valderrama A, Zhang S, Enzinger PC. Analysis of quality-adjusted survival time without symptoms or toxicity for pembrolizumab plus chemotherapy as treatment for previously untreated participants with advanced or metastatic esophageal cancer. Qual Life Res. 2026 Feb 1;35(3):58. doi: 10.1007/s11136-025-04109-4.","pmid":"41620988","type":"DERIVED"},{"citation":"Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. Oncologist. 2024 Oct 3;29(10):e1324-e1335. doi: 10.1093/oncolo/oyae087.","pmid":"38815152","type":"DERIVED"},{"citation":"Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus. 2024 Jul;21(3):306-318. doi: 10.1007/s10388-024-01053-z. Epub 2024 Apr 12.","pmid":"38607538","type":"DERIVED"},{"citation":"Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.","pmid":"37139963","type":"DERIVED"},{"citation":"Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7.","pmid":"35668304","type":"DERIVED"},{"citation":"Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8.","pmid":"35394255","type":"DERIVED"},{"citation":"Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.","pmid":"34454674","type":"DERIVED"},{"citation":"Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Ozguroglu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.","pmid":"30735435","type":"DERIVED"}],"start_date":{"date":"2017-07-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)","url":"https://clinicaltrials.gov/study/NCT03189719"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-590-nct03189719"}