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Trial Summary

An open label Phase II 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



ACTRN/NCT /ethics:


Scientific 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 (AHEAD-MERIT)

Sponsor / Cooperative group:

BioNTech SE

Trial & Patient Characteristics

Cancer TypeHead & neck
Trial TypeTreatment
PhasePhase II
Age Range18 years and older
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2021-01-07
Anticipated End Date2025-05-01

Participating Hospitals

HospitalCancer Research SA
Clinical Trial CoordinatorKelly Mead
Phone08 8359 2565
Principal InvestigatorDr Sarwan Bishnoi
Recruitment StatusRecruiting