{"preliminary_commentary":{"by_channel":{"x_thread":42,"podcast":4,"youtube":1},"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\": \"NCT02494583\", \"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 advanced gastric or gastroesophageal junction adenocarcinoma","name":"KEYNOTE-062","nct_id":"NCT02494583","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-062-nct02494583. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). 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 for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","label":"Pembrolizumab Monotherapy (Pembro Mono)","type":"EXPERIMENTAL"},{"description":"Participants will receive pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 twice a day (BID) on Days 1-14 Q3W may be substituted for 5-FU per local guidelines. 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 for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","label":"Pembrolizumab + SOC Chemotherapy (Pembro Combo)","type":"EXPERIMENTAL"},{"description":"Participants receive placebo IV Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 BID on Days 1-14 Q3W may be substituted for 5-FU per local guidelines.","label":"Placebo + SOC Chemotherapy (SOC)","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-06-06","type":"ACTUAL"},"conditions":["Gastric Adenocarcinoma"],"enrollment":{"count":763,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"5-FU","otherNames":[],"type":"DRUG"},{"name":"Capecitabine","otherNames":[],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2023-04-13","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-03-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)","timeFrame":"Up to approximately 36 months"},{"measure":"Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10","timeFrame":"Up to approximately 42 months"}],"references":[{"citation":"Janjigian YY, Cecchini M, Shitara K, Enzinger PC, Wainberg ZA, Chau I, Satoh T, Lee J, Nebozhyn M, Loboda A, Kobie J, Vajdi A, Shih CS, Cristescu R, Cao ZA. Genomic Landscape of Late-Stage Gastric Cancer: Analysis From KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Studies. JCO Precis Oncol. 2025 Mar;9:e2400456. doi: 10.1200/PO-24-00456. Epub 2025 Mar 21.","pmid":"40117530","type":"DERIVED"},{"citation":"Muro K, Shitara K, Yamaguchi K, Yoshikawa T, Satake H, Hara H, Sugimoto N, Machida N, Goto M, Kawakami H, Amagai K, Omuro Y, Esaki T, Hironaka S, Nishina T, Komatsu Y, Matsubara H, Shiratori S, Han S, Satoh T, Ohtsu A. Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer. J Gastrointest Cancer. 2023 Sep;54(3):951-961. doi: 10.1007/s12029-023-00920-9. Epub 2023 Apr 10.","pmid":"37037952","type":"DERIVED"},{"citation":"Satake H, Lee KW, Chung HC, Lee J, Yamaguchi K, Chen JS, Yoshikawa T, Amagai K, Yeh KH, Goto M, Chao Y, Lam KO, Han SR, Shiratori S, Shah S, Shitara K. Pembrolizumab or pembrolizumab plus chemotherapy versus standard of care chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Asian subgroup analysis of KEYNOTE-062. Jpn J Clin Oncol. 2023 Mar 7;53(3):221-229. doi: 10.1093/jjco/hyac188.","pmid":"36533429","type":"DERIVED"},{"citation":"Lee KW, Van Cutsem E, Bang YJ, Fuchs CS, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Chao J, Wainberg ZA, Cao ZA, Aurora-Garg D, Kobie J, Cristescu R, Bhagia P, Shah S, Tabernero J, Shitara K, Wyrwicz L. Association of Tumor Mutational Burden with Efficacy of Pembrolizumab+/-Chemotherapy as First-Line Therapy for Gastric Cancer in the Phase III KEYNOTE-062 Study. Clin Cancer Res. 2022 Aug 15;28(16):3489-3498. doi: 10.1158/1078-0432.CCR-22-0121.","pmid":"35657979","type":"DERIVED"},{"citation":"Chao J, Fuchs CS, Shitara K, Tabernero J, Muro K, Van Cutsem E, Bang YJ, De Vita F, Landers G, Yen CJ, Chau I, Elme A, Lee J, Ozguroglu M, Catenacci D, Yoon HH, Chen E, Adelberg D, Shih CS, Shah S, Bhagia P, Wainberg ZA. Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials. JAMA Oncol. 2021 Jun 1;7(6):895-902. doi: 10.1001/jamaoncol.2021.0275.","pmid":"33792646","type":"DERIVED"},{"citation":"Shitara K, Van Cutsem E, Bang YJ, Fuchs C, Wyrwicz L, Lee KW, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Mansoor W, Braghiroli MI, Karaseva N, Caglevic C, Villanueva L, Goekkurt E, Satake H, Enzinger P, Alsina M, Benson A, Chao J, Ko AH, Wainberg ZA, Kher U, Shah S, Kang SP, Tabernero J. Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Oct 1;6(10):1571-1580. doi: 10.1001/jamaoncol.2020.3370.","pmid":"32880601","type":"DERIVED"}],"start_date":{"date":"2015-07-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)","url":"https://clinicaltrials.gov/study/NCT02494583"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-062-nct02494583"}