{"preliminary_commentary":{"by_channel":{"podcast":3,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"JAVELIN HEAD AND NECK 100","nct_id":"NCT02952586","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=javelin-head-and-neck-100-nct02952586. The price is an estimate of verified HCP 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":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"* Avelumab 10 mg/kg IV: Day 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; and Q2W for 12 months during the Maintenance Phase\n* Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase\n* Intensity Modulated Radiation Therapy (IMRT) 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase","label":"Avelumab + SOC Chemoradiation Therapy","type":"EXPERIMENTAL"},{"description":"* Placebo IV matching avelumab: Days 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; Q2W for 12 months during the Maintenance Phase\n* Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase\n* IMRT 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase","label":"Placebo + SOC CRT","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2020-08-25","type":"ACTUAL"},"conditions":["Squamous Cell Carcinoma of the Head and Neck"],"enrollment":{"count":697,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Avelumab","otherNames":[],"type":"DRUG"},{"name":"Chemoradiation","otherNames":[],"type":"OTHER"}],"last_update":"2021-09-22","lead_sponsor":"Pfizer","official_title":"A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-12-23","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator","timeFrame":"From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months)"}],"references":[{"citation":"Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.","pmid":"33794205","type":"DERIVED"}],"start_date":{"date":"2016-11-28","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)","url":"https://clinicaltrials.gov/study/NCT02952586"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/javelin-head-and-neck-100-nct02952586"}