{"commentary":{"count":47,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":21,"podcast":21,"x_thread":5},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02358031\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT02358031","nct_id":"NCT02358031","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02358031. The price is fixed at order. We build the report after 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: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years).","label":"Pembrolizumab Monotherapy (Pembro Mono)","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \\~2 years); plus cisplatin 100 mg/m\\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]); plus 5-FU 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","label":"Pembrolizumab + Chemotherapy (Pembro Combo)","type":"EXPERIMENTAL"},{"description":"Participants receive cetuximab on Day 1 at a dose of 400 mg/m\\^2 IV, and then 250 mg/m\\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\] for platinum-based therapy); plus 5-FU 1000 mg/m\\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \\[up to \\~4 months\\]).","label":"Cetuximab + Chemotherapy (Control)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-07-19","type":"ACTUAL"},"conditions":["Recurrent Head and Neck Cancer","Metastatic Head and Neck Cancer"],"enrollment":{"count":882,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Cisplatin","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"5-FU","type":"DRUG"},{"name":"Cetuximab","type":"BIOLOGICAL"}],"last_update":"2025-07-18","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-02-25","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Combo vs Control: Overall Survival (OS) in All Participants","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: OS in All Participants","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥1","timeFrame":"Up to approximately 47 months"},{"measure":"Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥20","timeFrame":"Up to approximately 47 months"}],"references":[{"citation":"Tahara M, Greil R, Rischin D, Harrington KJ, Burtness B, de Castro G, Psyrri A, Brana I, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak WZW, Lin J, Gumuscu B, Lerman N, Soulieres D. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up from the randomized phase III KEYNOTE-048 study. Eur J Cancer. 2025 May 15;221:115395. doi: 10.1016/j.ejca.2025.115395. Epub 2025 Apr 4.","pmid":"40262400","type":"RESULT"},{"citation":"Oridate N, Takahashi S, Tanaka K, Shimizu Y, Fujimoto Y, Matsumoto K, Yokota T, Yamazaki T, Takahashi M, Ueda T, Hanai N, Yamaguchi H, Hara H, Yoshizaki T, Yasumatsu R, Nakayama M, Shiga K, Fujii T, Mitsugi K, Takahashi K, Nohata N, Gumuscu B, Lerman N, Tahara M. First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE-048. Int J Clin Oncol. 2024 Dec;29(12):1825-1839. doi: 10.1007/s10147-024-02632-x. Epub 2024 Oct 9.","pmid":"39382718","type":"DERIVED"},{"citation":"Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004.","pmid":"37699333","type":"DERIVED"},{"citation":"Takahashi S, Oridate N, Tanaka K, Shimizu Y, Fujimoto Y, Matsumoto K, Yokota T, Yamazaki T, Takahashi M, Ueda T, Hanai N, Yamaguchi H, Hara H, Yoshizaki T, Yasumatsu R, Nakayama M, Shiga K, Fujii T, Mitsugi K, Takahashi K, Nohata N, Gumuscu B, Swaby RF, Tahara M. First-line pembrolizumab +/- chemotherapy for recurrent/metastatic head and neck cancer: Japanese subgroup of KEYNOTE-048. Int J Clin Oncol. 2022 Dec;27(12):1805-1817. doi: 10.1007/s10147-022-02233-6. Epub 2022 Oct 20.","pmid":"36264378","type":"DERIVED"},{"citation":"Harrington KJ, Burtness B, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790-802. doi: 10.1200/JCO.21.02508. Epub 2022 Oct 11.","pmid":"36219809","type":"DERIVED"},{"citation":"Rischin D, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak WZW, Hong RL, Mendoza RG, Jia L, Chirovsky D, Norquist J, Jin F, Burtness B. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048. Oral Oncol. 2022 May;128:105815. doi: 10.1016/j.oraloncology.2022.105815. Epub 2022 Apr 2.","pmid":"35381576","type":"DERIVED"},{"citation":"Burtness B, Rischin D, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Ge J, Swaby RF, Gumuscu B, Harrington K. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321-2332. doi: 10.1200/JCO.21.02198. Epub 2022 Mar 25.","pmid":"35333599","type":"DERIVED"},{"citation":"Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.","pmid":"31679945","type":"DERIVED"}],"start_date":{"date":"2015-03-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)","url":"https://clinicaltrials.gov/study/NCT02358031"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02358031"}