{"entity":{"id":"nct04534205","kind":"trial","name":"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","aka":["AHEAD-MERIT"],"tldr":"A phase 2/3 trial testing BNT113 in head and neck squamous cell carcinoma, active and no longer recruiting.","summary":"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 is a phase 2/3 interventional study registered as NCT04534205, led by BioNTech SE, and active but no longer recruiting on the registry. Official title: An Open-label Phase II/III Randomised 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. Planned enrolment is 358 participants (actual). The study started in 2021-01-07 and primary completion is expected in 2028-08. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04534205","url":"https://clinicaltrials.gov/study/NCT04534205"}],"tags":["ctgov-ingest"],"related":[],"cancers":["head-and-neck","hpv-positive-oropharyngeal-cancer","recurrent-metastatic-hnscc"],"sections":[],"technologies":[],"targets":[],"drugs":["bnt113"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04534205","phase":"2/3","setting":"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","sponsor":"BioNTech SE","started":"2021-01-07","startedType":"actual","enrolled":358,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04534205/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-positive-oropharyngeal-cancer","kind":"cancer","name":"HPV-positive oropharyngeal cancer","route":"/cancers/hpv-positive-oropharyngeal-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"drug":[{"id":"bnt113","kind":"drug","name":"BNT113","route":"/drugs/bnt113/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"}]}}