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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
HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
Phone08 8206 4835
Principal InvestigatorDr Shawgi Sukumaran
Recruitment StatusRecruiting