BNT113-01 -AHEAD-MERIT
12 Apr 2022
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
Acronym:
AHEAD-MERIT
ACTRN/NCT /ethics:
NCT04534205
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 Type | Head & neck |
|---|---|
| Trial Type | Treatment |
| Phase | Phase II |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | Locally Recurrent or Locally Advanced; Metastatic or Widespread |
| Anticipated Start Date | 2021-01-07 |
| Anticipated End Date | 2025-05-01 |
Participating Hospitals
| Hospital | Cancer Research SA |
|---|---|
| Clinical Trial Coordinator | Kelly Mead |
| admin@cancerresearchsa.com.au | |
| Phone | 08 8359 2565 |
| Principal Investigator | Dr Sarwan Bishnoi |
| Recruitment Status | Recruiting |
| Hospital | Flinders Medical Centre |
|---|---|
| Clinical Trial Coordinator | Hannah Adelson |
| Hannah.adelson@sa.gov.au | |
| Phone | 08 8206 4835 |
| Principal Investigator | Dr Shawgi Sukumaran |
| Recruitment Status | Recruiting |