{"preliminary_commentary":{"by_channel":{"youtube":117,"podcast":99,"x_thread":73,"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\": \"NCT03615326\", \"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":{"generated_at":"2026-11-02T20:25:20.522Z","note":"Automated from the 40 newest of 292 indexed sources (May 2026 – Nov 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.","passages_read":40,"text":"- Whether KEYNOTE-811 remains an appropriate option alongside newer first-line regimens\n- How to interpret comparisons between KEYNOTE-811 and zanidatamab regimens without direct comparative evidence\n- Whether PD-L1 expression identifies patients who benefit from pembrolizumab\n\nAlso discussed: biomarker testing access."},"drugs_tested":[["pembrolizumab","trastuzumab"]],"indication":"first-line HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma","name":"KEYNOTE-811","nct_id":"NCT03615326","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-811-nct03615326. 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 received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.","label":"Global Pembrolizumab + Standard of Care First Course","type":"EXPERIMENTAL"},{"description":"Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with investigator's choice of FP or CAPOX chemotherapy.","label":"Global Standard of Care","type":"ACTIVE_COMPARATOR"},{"description":"Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.","label":"Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin","type":"EXPERIMENTAL"},{"description":"Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.","label":"Japan Trastuzumab + S-1 Plus Oxaliplatin","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-11-12","type":"ACTUAL"},"conditions":["Gastric Neoplasms","Gastroesophageal Junction Adenocarcinoma"],"enrollment":{"count":738,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["Keytruda®","MK-3475"],"type":"BIOLOGICAL"},{"name":"Placebo","otherNames":[],"type":"BIOLOGICAL"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"5-FU","otherNames":[],"type":"DRUG"},{"name":"Oxaliplatin","otherNames":[],"type":"DRUG"},{"name":"Capecitabine","otherNames":[],"type":"DRUG"},{"name":"S-1","otherNames":[],"type":"DRUG"},{"name":"Trastuzumab","otherNames":["Herceptin®"],"type":"BIOLOGICAL"}],"last_update":"2026-08-26","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-03-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR","timeFrame":"Up to 46 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to 63 months"}],"references":[{"citation":"Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin SK, Van Cutsem E, Tabernero J, Li K, Shih CS, Bhagia P, Rha SY; KEYNOTE-811 Investigators. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Lancet. 2023 Dec 9;402(10418):2197-2208. doi: 10.1016/S0140-6736(23)02033-0. Epub 2023 Oct 20.","pmid":"37871604","type":"RESULT"},{"citation":"Janjigian YY, Kawazoe A, Bai Y, Xu J, Lonardi S, Metges JP, Yanez P, Wyrwicz LS, Shen L, Ostapenko Y, Bilici M, Chung HC, Shitara K, Qin S, Van Cutsem E, Tabernero J, Luo S, Mahave M, Tang Y, Lowery M, Monteiro MMF, Xu L, Shih CS, Sharan KP, Bhagia P, Rha SY. Pembrolizumab in HER2-Positive Gastric Cancer. N Engl J Med. 2024 Oct 10;391(14):1360-1362. doi: 10.1056/NEJMc2408121. Epub 2024 Sep 14. No abstract available.","pmid":"39282917","type":"RESULT"},{"citation":"Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.","pmid":"34912120","type":"DERIVED"},{"citation":"Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.","pmid":"33167735","type":"DERIVED"}],"start_date":{"date":"2018-10-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)","url":"https://clinicaltrials.gov/study/NCT03615326"},"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-811-nct03615326"}