{"preliminary_commentary":{"by_channel":{"x_thread":51,"youtube":47,"podcast":44,"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\": \"NCT03221426\", \"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":"locally advanced gastric or gastroesophageal junction adenocarcinoma","name":"KEYNOTE-585","nct_id":"NCT03221426","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-585-nct03221426. 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":"XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle.\n\nAdjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg IV infusion on Day 1 Q3W for up to 11 additional cycles.","label":"Pembrolizumab + XP/FP","type":"EXPERIMENTAL"},{"description":"Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.\n\nAdjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\\^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m\\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.","label":"Placebo + XP/FP","type":"PLACEBO_COMPARATOR"},{"description":"FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\\^2 via IV infusion, oxaliplatin 85 mg/m\\^2 via IV infusion, 5FU 2600 mg/m\\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).\n\nAdjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m\\^2, oxaliplatin 85 mg/m\\^2, 5FU 2600 mg/m\\^2, and leucovorin 200 mg/m\\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.","label":"Pembrolizumab+FLOT Cohort","type":"EXPERIMENTAL"},{"description":"Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\\^2 via IV infusion, oxaliplatin 85 mg/m\\^2 via IV infusion, 5FU 2600 mg/m\\^2 via IV infusion, and leucovorin 200 mg/m\\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations).\n\nAdjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\\^2 via IV infusion, oxaliplatin 85 mg/m\\^2 via IV infusion, 5FU 2600 mg/m\\^2 via IV infusion, and leucovorin 200 mg/m\\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.","label":"Placebo+FLOT Cohort","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-04-23","type":"ACTUAL"},"conditions":["Gastric Cancer","Gastroesophageal Junction Cancer"],"enrollment":{"count":1007,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":["Normal saline solution"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["PLATINOL®"],"type":"DRUG"},{"name":"Capecitabine","otherNames":["XELODA®"],"type":"DRUG"},{"name":"5-fluorouracil","otherNames":["ADRUCIL®","5FU"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["TAXOTERE®"],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":["ELOXATIN®"],"type":"DRUG"},{"name":"Leucovorin","otherNames":["WELLCOVORIN®"],"type":"DRUG"}],"last_update":"2026-03-09","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-02-16","type":"ACTUAL"},"primary_outcomes":[{"measure":"Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","timeFrame":"Up to approximately 75 months"},{"measure":"Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","timeFrame":"Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)"},{"measure":"Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms","timeFrame":"Up to approximately 75 months"},{"measure":"Number of Participants Who Experienced One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts","timeFrame":"Up to approximately 70 months"},{"measure":"Number of Participants Who Discontinued Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts","timeFrame":"Up to approximately 17 months"}],"references":[{"citation":"Shitara K, Rha SY, Wyrwicz LS, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Dib Bartolomeo M, Lonardi S, Tabernero J, Van Cutsem E, Janjigian YY, Oh DY, Xu J, Fang X, Shih CS, Bhagia P, Bang YJ; KEYNOTE-585 investigators. Neoadjuvant and adjuvant pembrolizumab plus chemotherapy in locally advanced gastric or gastro-oesophageal cancer (KEYNOTE-585): an interim analysis of the multicentre, double-blind, randomised phase 3 study. Lancet Oncol. 2024 Feb;25(2):212-224. doi: 10.1016/S1470-2045(23)00541-7. Epub 2023 Dec 19.","pmid":"38134948","type":"RESULT"},{"citation":"Shitara K, Rha SY, Wyrwicz L, Oshima T, Karaseva N, Osipov M, Yasui H, Yabusaki H, Afanasyev S, Park YK, Al-Batran SE, Yoshikawa T, Yanez P, Pietrantonio F, Lonardi S, Fang X, Guan Y, Valderrama A, Leconte P, Bhagia P, Bang YJ; KEYNOTE-585 Investigators. Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study. J Clin Oncol. 2025 Oct 10;43(29):3152-3159. doi: 10.1200/JCO-25-00486. Epub 2025 Aug 19.","pmid":"40829093","type":"DERIVED"},{"citation":"Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.","pmid":"35623069","type":"DERIVED"},{"citation":"Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.","pmid":"30777447","type":"DERIVED"}],"start_date":{"date":"2017-10-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)","url":"https://clinicaltrials.gov/study/NCT03221426"},"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-585-nct03221426"}