{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":"AHEAD-MERIT","nct_id":"NCT04534205","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ahead-merit-nct04534205. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"AHEAD-MERIT","arms":[{"description":"Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.","label":"Part A (Safety Run-In) - BNT113 + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"BNT113 in combination with pembrolizumab.","label":"Part B (Randomized phase) - BNT113 + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Pembrolizumab monotherapy.","label":"Part B (Randomized phase) - Pembrolizumab monotherapy","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-08","type":"ESTIMATED"},"conditions":["Unresectable Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer"],"enrollment":{"count":358,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"BNT113","otherNames":[],"type":"BIOLOGICAL"},{"name":"Pembrolizumab","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-10-14","lead_sponsor":"BioNTech SE","official_title":"An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2028-08","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumab","timeFrame":"up to 27 months"},{"measure":"Part B - Overall survival (OS)","timeFrame":"up to 48 months"},{"measure":"Part B - Progression-free survival (PFS)","timeFrame":"up to 48 months"}],"references":[],"start_date":{"date":"2021-01-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1","url":"https://clinicaltrials.gov/study/NCT04534205"},"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/ahead-merit-nct04534205"}