This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1" and "MVA") that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells. This is a first-in-human study to evaluate the safety and immunogenicity of ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and intermediate risk localised prostate cancer patients who have either decided to have their prostate removed or are stable on active surveillance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Metronomic cyclophosphamide (50mg bd)
University of Oxford
Oxford, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Vaccine safety and immunogenicity
Development or increase in anti-5T4 cellular and humoral responses in patients treated with CHAMVA or CHAMVA + CTX
Time frame: Up to 52 weeks
Cellular and humoral immune response with CHAMVA
Development or increase in anti-5T4 cellular and humoral responses in patients treated with the CHAMVA vaccination regimes
Time frame: Up to 52 weeks
Cellular and humoral immune response with MVA
Development or increase in anti-5T4 cellular and humoral response in patients treated with the MVA vaccination regimes.
Time frame: Up to 52 weeks
PSA level change secondary to vaccination
PSA level decrease in patients treated with CHAMVA or MVA vaccination at week 4,8 or 12.
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
MRI or Gleason score change secondary to vaccination
Reduction of tumour burden or Gleason score at weeks 4, 8 or 12.
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
Regulatory T-cell response
Change in the frequency of regulatory T-cells measured in blood or tumour samples from patients treated with metronomic cyclophosphamide compared to patients not receiving cyclophosphamide
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
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