VB-C-03 Head and Neck Squamous Cell Carcinoma
Research type
Research Study
Full title
A Phase 1/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity of VB10.16 in Combination with Pembrolizumab in Patients with Unresectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma
IRAS ID
1007089
Contact name
Lena Finnesand
Contact email
Sponsor organisation
Nykode Therapeutics ASA
Eudract number
2022-002029-81
Research summary
Head and Neck Squamous Cell Carcinoma (HNSCC) is the seventh most common cancer worldwide. Around 30% of HNSCC are caused by Human Papilloma Viruses (HPV). This trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine. In this trial, VB10.16 is given in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or unresectable recurrent PD-L1 positive HNSCC. VB10.16 is a therapeutic vaccine, with the aim of stimulating the body's immune response against the tumour. VB10.16 will be given into muscle using a needle-free injection system (PharmaJet Stratis®). The immune system will recognise parts of the VB10.16 vaccine as a foreign substance, and consequently, the immune system may generate an immune response to fight the HPV-positive tumour.
In the first part of the trial (Escalation Phase), 3 different doses of VB10.16 will be used in combination with a standard fixed dose of pembrolizumab. The number of injections each participant will receive at each treatment visit will depend on the dose of VB10.16 they are assigned to; between 2 and 6 injections each time they receive VB10.16.
In the second part of the trial (Dose Expansion Phase), participants will receive either the highest dose of VB10.16 considered to be safe after the Dose Escalation Phase has completed, or the lowest dose. Allocation of dosage (high dose or low dose) will be decided by randomization. Two in 3 participants (67%) will receive the high dose and 1 in 3 participants (33%) will receive the low dose.
The dose of pembrolizumab will be at a standard fixed dose. The first year of the trial participants will receive VB10.16 in combination with pembrolizumab. After this period participants can continue pembrolizumab treatment for an additional year. This study is being sponsored by Nykode Therapeutics. The Sponsor’s collaborator is MSD.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0032
Date of REC Opinion
22 Jun 2023
REC opinion
Further Information Favourable Opinion