{"commentary":{"count":12,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":6,"podcast":5,"youtube":1},"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\": \"NCT04459715\", \"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":"NCT04459715","nct_id":"NCT04459715","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04459715. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants received:\n\nConcomitant chemo-radiation therapy period (Cycles 1-3):\n\n* Radiotherapy\n* Cisplatin\n* Xevinapant (Debio 1143)\n\nMonotherapy period (Cycles 4-6):\n\n• Xevinapant (Debio 1143)","label":"Xevinapant (Debio 1143)","type":"EXPERIMENTAL"},{"description":"Participants received:\n\nConcomitant chemo-radiation therapy period (Cycles 1-3):\n\n* Radiotherapy\n* Cisplatin\n* Matched placebo\n\nMonotherapy period (Cycles 4-6):\n\n• Matched placebo","label":"Placebo","type":"ACTIVE_COMPARATOR"}],"collaborators":["GORTEC (Head and Neck Oncology and Radiotherapy Group)","Merck KGaA, Darmstadt, Germany"],"completion_date":{"date":"2024-09-18","type":"ACTUAL"},"conditions":["Squamous Cell Carcinoma of the Head and Neck"],"enrollment":{"count":730,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Xevinapant (Debio 1143)","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Intensity Modulation Radiation Therapy (IMRT)","type":"RADIATION"},{"name":"Placebo","type":"DRUG"}],"last_update":"2025-10-08","lead_sponsor":"EMD Serono Research & Development Institute, Inc.","official_title":"A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-09-18","type":"ACTUAL"},"primary_outcomes":[{"measure":"Event-Free Survival (EFS) as Assessed by Blinded Independent Review Committee (BIRC)","timeFrame":"From randomization to the earliest between any EFS event or End of Study (EOS) (up to 188 weeks and 5 days)"}],"references":[{"citation":"Bourhis J, Licitra LF, Burtness B, Psyrri A, Haddad R, Harrington K, Cohen EEW, Tao Y, Tiscoski KA, Matitashvili A, Tahara M, Sukari A, Rutkowski T, Salas S, Nauwelaerts H, Scheerlinck R, Ha NT, Schroeder A, Rodriguez-Gutierrez A, Schoenfeld JD. Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study. J Clin Oncol. 2025 Oct 10;43(29):3209-3220. doi: 10.1200/JCO-25-00272. Epub 2025 Sep 3.","pmid":"40902136","type":"DERIVED"},{"citation":"Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.","pmid":"35172587","type":"DERIVED"}],"start_date":{"date":"2020-08-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)","url":"https://clinicaltrials.gov/study/NCT04459715"},"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/nct04459715"}