VERSATILE-002

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Multi-Center Study of PDS0101 (R-DOTAP [Versamune®] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-Risk Human Papillomavirus-16 (HPV16) Infection

• IRAS ID

  1004811

• Contact name

  Nathalie Riebel

• Contact email

  nriebel@PDSbiotech.com

• Sponsor organisation

  PDS Biotechnology

• Eudract number

  2021-004046-38

• ISRCTN Number

  ISRCTN15021247

• Clinicaltrials.gov Identifier

  NCT04260126

• Research summary

  The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously (“IV;” into the vein). Participants are being invited to take part in this research study because he/she has been diagnosed with recurrent or metastatic Head and Neck Cancer (HNC) and High-risk Human Papillomavirus-16 (HPV16) infection. The most common type of HNC is head and neck squamous cell carcinoma (HNSCC), the sixth most common cancer worldwide. HPV has been clearly implicated as the causative agent in a subset of HNC. The most commonly implicated HPV subtype in HNC is HPV16, accounting for over 80% of HPV+ HNC. PDS0101 is an investigational therapeutic cancer vaccine designed to boost the body’s immune response against HPV16. PDS0101 contains 2 active components: The first is called R-DOTAP and is included in the vaccine to boost the immune system’s response against the HPV viral proteins. The second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. In order to be able to participate, the participant will need to provide a blood sample to find out their tissue type. Current therapies for HNC can include; surgery, radiation therapy, chemotherapy, targeted therapy and immunotherapy. The sponsor of this study is PDS Biotechnology Corporation. Approximately 95 people, aged 18 years or older are expected to be in this study which will be conducted at 40 study sites in 5 countries worldwide.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  22/LO/0124

• Date of REC Opinion

  8 Apr 2022

• REC opinion

  Further Information Favourable Opinion