NEOVACC

  • Research type

    Research Study

  • Full title

    Targeting Non-Small Cell Lung Cancer with Doggybone Personalised Cancer DNA Vaccines (dbPCV)

  • IRAS ID

    1010332

  • Contact name

    Christian Ottensmeier

  • Contact email

    C.Ottensmeier@liverpool.ac.uk

  • Sponsor organisation

    University of Liverpool

  • ISRCTN Number

    ISRCTN11752949

  • Research summary

    Personalised cancer vaccines (PCV) are a new approach for training a person’s immune system to attack the cancer. In this trial for patients with non-small cell lung cancer (NSCLC), each person receives a unique vaccine, made from their own genetic information (DNA), called a doggybone vaccine . We will add the vaccine to a common therapy for NSCLC, a drug called pembrolizumab. Pembrolizumab is used on its own to treat NSCLC if at least 50% of the cancer cells show a molecule called PDL1 (programmed-death ligand 1). Pembrolizumab is given for up to 2 years but may be stopped early if it does not work or if it causes side effects that make it unsafe to continue.
    A small sample of the cancer tissue (biopsy) will be taken to look at the genetic differences in cancer cells compared to normal cells. This genetic information will be used to make the vaccine. Participants will continue pembrolizumab treatment at the same time. When the vaccine is ready, participants will receive their own vaccine every 3 weeks for 24 weeks and every 6 weeks for the remainder of the time the participant is in the trial. The vaccine will be given into a muscle, using a needle-free injector called the PharmaJet. Pembrolizumab and vaccine treatment will continue at the same time for up to a maximum of 2 years.
    PCVs have been safe in other trials but every participant will be followed carefully for side effects. A key aim of the study is to work out if the vaccine can train the immune system in the desired way and if this links to an improvement in the cancer. We will monitor the cancer carefully and will collect a second cancer biopsy during treatment, blood samples over time and on two occasions a larger sample of some blood cells (white blood cells) in a process called leukapheresis. These samples will be used to see whether the vaccine has trained participant cells to recognise and fight the cancer.

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    25/LO/0177

  • Date of REC Opinion

    17 Apr 2025

  • REC opinion

    Further Information Favourable Opinion