Phase I/IIa trial of ChAdOx1 & MVA vaccines against MAGE-A3 & NY-ESO-1

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I/IIa trial of Chimpanzee Adenovirus Oxford 1 (ChAdOx1) and Modified Vaccinia Ankara (MVA) vaccines against MAGE-A3 and NY-ESO-1 with standard of care treatment (chemotherapy and an immune checkpoint inhibitor)

• IRAS ID

  290572

• Contact name

  Fiona Blackhall

• Contact email

  fiona.blackhall@christie.nhs.uk

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2019-003015-64

• Clinicaltrials.gov Identifier

  NCT04908111

• Duration of Study in the UK

  4 years, 3 months, 27 days

• Research summary

  This clinical trial is looking at two new vaccines called ChAdOx1-MAGEA3-NYESO and MVA-MAGEA3 given with patients’ standard of care treatment (chemotherapy and an immune checkpoint inhibitor).

  Patients with non-small cell lung cancer (NSCLC) will be entered into the trial as this tumour type is commonly known to have MAGE-A3 and NY-ESO-1 proteins on their cancer cells. The vaccines contain harmless parts of these proteins allowing them to show these proteins to the immune system. We expect the immune system to ‘learn’ that these proteins are foreign to the body. The immune system should then attack the proteins on the cancer cells, killing them. We expect the vaccines will help the chemotherapy and immune checkpoint inhibitor to work better.

  This is a first-in-human clinical trial which has two stages:

  A ‘safety run in’ stage where six evaluable patients will receive the trial vaccines with standard of care treatment to confirm they are safe before opening the next stage.

  A ‘rolling recruitment’ stage where approximately 80 patients will be randomly allocated by computer (randomised) to one of two groups (arms). Patients in Arm A will receive the vaccines with their standard of care treatment and patients in Arm B will continue with their standard of care treatment alone. There is a 1 in 2 chance patients will receive the vaccines.

  The main aims of this trial are to find out:
  - More about potential side effects of the vaccines and how they can be managed
  - Whether the vaccines with standard treatment are better at shrinking cancer than just the standard of care treatment patients receive
  - What happens to the vaccines inside the body

  This trial will be conducted at approximately 10 sites across the UK.

  This trial is sponsored by Cancer Research UK (CRUK). The vaccines are developed by Vaccitech Ltd.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/LO/0115

• Date of REC Opinion

  20 Apr 2021

• REC opinion

  Further Information Favourable Opinion