{"preliminary_commentary":{"by_channel":{"podcast":39,"youtube":36,"x_thread":28},"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\": \"NCT03675737\", \"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":"first-line HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma","name":"KEYNOTE-859","nct_id":"NCT03675737","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-859-nct03675737. 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) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen).\n\nParticipants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).","label":"Pembrolizumab + Chemotherapy (FP or CAPOX regimen)","type":"EXPERIMENTAL"},{"description":"Participants receive placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\\^2 IV on Day 1 Q3W and 5FU 800 mg/m\\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).","label":"Placebo + Chemotherapy (FP or CAPOX regimen)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-03-03","type":"ACTUAL"},"conditions":["Stomach Neoplasms"],"enrollment":{"count":1579,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"Cisplatin","otherNames":["PLATINOL®"],"type":"DRUG"},{"name":"5-fluorouracil","otherNames":["ADRUCIL®","5FU"],"type":"DRUG"},{"name":"oxaliplatin","otherNames":["ELOXATIN®"],"type":"DRUG"},{"name":"capecitabine","otherNames":["XELODA®"],"type":"DRUG"},{"name":"Placebo for Pembrolizumab","otherNames":[],"type":"DRUG"}],"last_update":"2026-02-27","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-10-03","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS) in All Participants","timeFrame":"Up to 45.9 months"},{"measure":"Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1","timeFrame":"Up to 45.9 months"},{"measure":"Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10","timeFrame":"Up to 45.9 months"}],"references":[{"citation":"Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21.","pmid":"37875143","type":"RESULT"},{"citation":"Qin S, Bai Y, Li J, Pan H, Luo S, Qu Y, Ye F, Yang L, Liu T, Li W, Chen X, Yang J, Ying J, Lin X, Zhao L, Liang X, Mao Y, Guo R, Zuo Y, Bordia S, Li S. First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study. Adv Ther. 2025 Apr;42(4):1892-1906. doi: 10.1007/s12325-024-03069-4. Epub 2025 Mar 1.","pmid":"40025394","type":"RESULT"},{"citation":"Wyrwicz L, Kalampoki V, Valderrama A, Young K. Pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction cancer: KEYNOTE-859 Q-TWiST analysis. Immunotherapy. 2026 Feb;18(3):161-167. doi: 10.1080/1750743X.2026.2647579. Epub 2026 Apr 11.","pmid":"41964430","type":"DERIVED"},{"citation":"Yasui H, Aizawa M, Yamaguchi K, Kawazoe A, Hara H, Tsuda M, Shoji H, Sugimoto N, Shibata N, Amagai K, Choda Y, Iwagami S, Esaki T, Kadowaki S, Shiratori S, Han S, Bordia S, Shitara K. First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study. Int J Clin Oncol. 2025 Oct;30(10):2003-2011. doi: 10.1007/s10147-025-02847-6. Epub 2025 Aug 1.","pmid":"40750941","type":"DERIVED"},{"citation":"Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12.","pmid":"33975465","type":"DERIVED"}],"start_date":{"date":"2018-11-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)","url":"https://clinicaltrials.gov/study/NCT03675737"},"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-859-nct03675737"}