A Phase 2 study of BNT113 in HPV16+ HNSCC patients expressing PD-L1
Research type
Research Study
Full title
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.
IRAS ID
288716
Contact name
Christian Ottensmeier
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2020-001400-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, months, days
Research summary
Head and neck squamous cell carcinoma (HNSCC) is the sixth commonest cancer worldwide. For the past 20 years, head and neck cancer has been associated with 5-year survival rate of 50%. Traditional risk-factors for HNSCC patients have included alcohol consumption and tobacco use. More recently, however, the incidence of HPV-related HNSCC is increasing, in line with the overall rise in the incidence of malignancies associated with HPV infection.
In recent years, numerous approaches have shown that the immune system can be ‘trained’ and strengthened to both engage and destroy cancer cells. BioNTech SE, the sponsor of this study, are developing BNT113, a novel treatment designed to instruct immune cells to recognise HPV16+ HNSCC cells and potentially destroy them. BNT113 will be given in combination with Pembrolizumab, a cancer medicine that works by activating immune cells to fight cancers cells and blocks the growth and spread of the cancer cells in the body. By giving BNT113 and pembrolizumab together, the goal is to increase the immune system response against cancer cells.
This is an open-label, controlled, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.
This trial has two parts. Part A, a Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomised Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to assess if the combination of the study drug with pembrolizumab works better to treat people with HNSCC than pembrolizumab alone.
This study will take place in approximately 160 centres in 20 countries. Approximately 12 to 18 people with HNSCC will be participating in Part A and 267 people in Part B.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0026
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion