AHEAD-MERIT

A Phase II trial assessing the safety, tolerability and efficacy of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as a first line therapy in patients with unresectable recurrent or metastatic HPV16+, PD-L1+ HNSCC (NCT04534205)

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Primary Endpoints

  • Part A: Occurrence of TEAEs
  • Part B: OS, ORR by independent central review
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Secondary Endpoints

  • ORR by investigator assessment, PFS, DCR, DoR
  • Occurrence of TEAEs, dose reduction and discontinuation of treatment due to TEAEs
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For additional details about the BioNTech AHEAD-MERIT trial, including study design, study sites, or other information, please visit www.clinicaltrials.gov (Identifier: NCT04534205) or contact the BioNTech team: email, medinfo@biontech.de.

aNot inclusive of all criteria. Refer to https://clinicaltrials.gov/ct2/show/NCT04534205 for full details. bSystemic therapy which was completed >6 months prior to randomization, if given as part of multimodal treatment for locally advanced disease is allowed. cPatients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 + pembrolizumab) within Part A until progression or unmanageable toxicity, but for ≤24 months of therapy followed by overall survival observation. dPreliminary results from the safety run-in set have been presented at the ESMO Immuno-Oncology Congress 2022.
CPS, Combined positive score; DCR, disease control rate; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; HNSCC, Head and neck squamous cell carcinoma; HPV16, Human papilloma virus 16; ORR, overall response rate; OS, overall survival; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.