Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Christian Ottensmeier
C.Ottensmeier@liverpool.ac.uk


Mrs Helen Eccleson
NEOVACCTrial@liverpool.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - NEOVACC: A personalised DNA vaccine for patients with advanced lung cancer
Back

NEOVACC: A personalised DNA vaccine for patients with advanced lung cancer

Recruiting

Open to: All Genders

Age: Mixed

Wirral

Medical Conditions

Non-small cell lung cancer (NSCLC) with PDL1 expression ≥50% which does not achieve tumour clearance with anti-PD1 treatment

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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. The vaccine will be added 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). 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Sep 2025 31 May 2026

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. The cancer will be monitored carefully, a second cancer biopsy will be collected during treatment, as well as 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.


Adult patients with histologically proven advanced or recurrent NSCLC with PDL1 expression ≥50% and where anti-PD1 immunotherapy is licensed as standard of care treatment

You can take part if:



You may not be able to take part if:


1. Demonstrated a complete response from previous treatments according to RECIST criteria.2. In the physician’s view are likely to have sufficient benefit from anti-PD1 treatment alone.3. Evidence of rapid disease progression, who cannot wait for vaccine production and must seek alternative treatment options.4. Active autoimmune disease likely to pose a risk for the safe administration of anti-PD1 or other immune activating agents; exceptions to this are atopic dermatitis and psoriasis not requiring systemic treatment. Topical and inhaled steroids are allowed.5. Significant immune related adverse event requiring anti-PD1 to be stopped or necessitating ongoing systemic immunosuppressive treatment. Patients who have required mycophenolate or infliximab for management of IO related toxicities are not eligible.6. Currently receiving any form of chemotherapy and have received chemotherapy in the previous 9 weeks prior to screening. 7. Any other experimental medications during trial participation and within 30 days of consent.8. History of confirmed inflammatory bowel disease.9. Previous organ transplantation.10. Known brain metastases.11. Greater than 10mg Prednisolone equivalent per day unless for replacement purposes (e.g. adrenal insufficiency).12. Active or previous malignancies of other types, which in the Investigator’s opinion would mean they are not a good candidate for the clinical trial; specifically excluded are patients with malignancies that even in the early stages carry a high immunosuppressive burden (for example CLL, Multiple myeloma).13. Received anti-PD1 or anti-PD-L1 in prior line of treatment. 14. Other vaccination within a week of trial vaccination.15. Known diagnosis of HIV or active hepatitis B or C. Participants who are HBV carriers and receiving anti-viral prophylaxis are excluded.16. Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the Investigator, may affect the participant’s ability to provide informed consent and undergo trial procedures.17. Women of child bearing potential (WOCBP) who are currently pregnant, lactating or breastfeeding. 18. WOCBP or participants with partners of child bearing potential who are unable or unwilling to use contraception during the trial. 19. Known allergy to any component of the IMP.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Clatterbridge Cancer Centre
    Clatterbridge Hospital Clatterbridge Road
    Wirral
    CH63 4JY

The expected benefit from the NEOVACC trial is the training of a person’s immune system to fight their cancer. It is unknown how well the vaccine will work and it is being investigated in humans for the first time. It is hoped that this trial will help show how the immune system responds to the NEOVACC personalised cancer vaccine. In the future, this may then help patients with NSCLC or many other types of cancer.
Blood samples: Where possible, these will be taken at the same time as routine blood sampling. Risks include some discomfort and bruising.
Leukapheresis: Risks include bruising, numbness to hands and feet from a drop in blood calcium levels. It will be performed by highly trained staff. Participants are closely monitored and staff are present to treat any side effects. Research leukapheresis is a safe, effective way of obtaining large numbers of white blood cells required for translational research.
Research bronchoscopy/EBUS/Navigational bronchoscopy: Risks of bronchoscopy include sedation, bleeding, discomfort, pneumothorax (<1%) and a small risk of death (1¬2 in 10000). Sedation risk will be minimised by using the least amount of sedation necessary with full monitoring and having reversal agents present for use if required. Bleeding risk is minimised by ensuring platelet counts and clotting are within safe parameters and use of cold saline or adrenaline to achieve haemostasis if necessary. Discomfort will be minimised by using anti¬tussives and local anaesthetic. There is a small risk of pneumothorax (<1%) if transbronchial biopsies/lymph node biopsies are performed, the participant will have a chest radiograph prior to discharge to ensure they do not have a pneumothorax if necessary. The risk of death is minimised by an experienced bronchoscopist reviewing the participant to ensure they are fit to undergo the bronchoscopy. Serial research bronchoscopies are well tolerated and are an established common investigation for many lung diseases. Having research bronchoscopies entails coming to the hospital for a few hours each time, which can be inconvenient to the participant.
Research CT/USS guided biopsy: Risks are similar to any CT or Ultrasound guided biopsy. Risks include bleeding and a 5-7% risk of a collapsed lung that requires a chest tube. Bleeding risk is minimised by ensuring the participant's platelet count and clotting are within safe parameters. Discomfort will be minimised by using local anaesthetic. The risk of pneumothorax is managed by careful participant selection and involvement of specialist interventional radiologists in a tertiary specialised Heart and Chest hospital. Having research image-guided biopsies entails coming to the hospital for a few hours each time, which can be inconvenient for participants.
Surgical research biopsy: Risks include pain, bleeding, infection, risk of a collapsed lung, small risk of death and risks associated with a general anaesthetic. The surgeon will detail the specific risks. Standard measures will be taken to minimise risks of pain, bleeding and infection. Risks are minimised by involving the thoracic surgeons' significant experience and expertise. Having research surgical biopsies entails coming to the hospital for up to a few days each time, which may be inconvenient to the participant.
Trial drug (NeoVACC): This is the first clinical trial of personalised doggybone DNA cancer vaccination (NeoVACC) in participants, therefore it is not known if there will be any side effects in humans. Participants will be carefully screened to ensure they are suitable for the trial and will be monitored carefully for side effects throughout the trial and treated as required. This will include regular reviews with examinations and blood tests. There is a dedicated 24-hour phone number for participants to contact the hospital if they feel unwell or to seek advice during treatment.
To minimise the burden of additional hospital visits on participants, most of the follow-ups will take place alongside standard of care visits.
The effects of the vaccine on an unborn foetus or a breastfeeding infant are unknown. As a result, women who are pregnant, breastfeeding or thinking of becoming pregnant will not be able to take part in the trial. To minimise this risk, if there is a chance a participant could become pregnant, they must have a negative pregnancy test at Screening and Baseline visits and before each treatment cycle to be able to take part in the trial. During the trial, all participants must agree to use a highly effective method of contraception and for 4 months after the final vaccination.
Radiation risk: Participants in this trial will have CT scans as part of their standard care. They may have up to 2 further research CT scans or cone beam CT scans (+/- fluoroscopy) to guide biopsies with CT guided biopsy or navigational bronchoscopy. These procedures use ionising radiation which may cause cancer many years or decades after exposure. In participants with this type of cancer, the chances of this happening as a consequence of taking part in this study are less than 1%.
Participants may also undergo non-ionising radiation from ultrasound used in bronchoscopy with endobronchial ultrasound or an ultrasound guided biopsy.

Prof Christian Ottensmeier
C.Ottensmeier@liverpool.ac.uk


Mrs Helen Eccleson
NEOVACCTrial@liverpool.ac.uk



The study is sponsored by University of Liverpool and funded by UK Research and Innovation; Medical Research Council.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN11752949

Or CPMS 66997

Last updated 14 November 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top