VAccination in Prostate caNCEr (VANCE)

  • Clinical Studies
  • Sheffield

NIHR

UK Clinical Trials, clinical research, clinical trial Sheffield

Primary Trial ID Number

NCT02390063

Summary
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 decided to have their prostate removed.

Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : ChAdOx1.5T4, Biological : MVA.5T4, Drug : Cyclophosphamide
Study Arm Groups : Group 1, Group 2, Group 1, Group 2, Group 3, Group 4, Group 2, Group 4

Intervention Type
See Interventions above
Primary Outcome Measures
Vaccine safety; Participants will be followed for the duration of the study, an expected average of 24 weeks; Vaccine immunogenicity; Participants will be followed for the duration of the study, an expected average of 24 weeks
Secondary Outcome Measures
Change in the frequency of regulatory T cells measured in blood and prostatectomy specimens from patients treated with metronomic CTX compared to patients not receiving CTX; From baseline to radical prostatectomy, an expected average of 12 weeks; Change in the number of tumour-infiltrating lymphocytes in prostatectomy specimens secondary to vaccination; From baseline to radical prostatectomy, an expected average of 12 weeks; PSA level change secondary to vaccination; Participants will be followed for the duration of the study, an expected average of 24 weeks; MRI or Gleason score change secondary to vaccination; From baseline to radical prostatectomy, an expected average of 12 weeks

Result Reports
This is available on the Clinicaltrials.gov website

Gender
Male
Age Range
18 Years – 70 Years
Who Can Participate
Patients
Number of Participants
32
Participant Inclusion Criteria
Inclusion Criteria:
– Males aged 18 to 70 years
– Histologically confirmed prostate cancer diagnosed on biopsy within 6 months
– Clinically localised, low or intermediate risk prostate cancer, i.e.:
– Gleason score ≤ 7
– Local tumour stage ≤T2b
– No evidence of metastases (Nx/N0 and Mx/M0)
– PSA ≤ 20 ng/ml
– Scheduled for and considered fit for radical prostatectomy
– Absence of any indication to perform urgent surgery that would not allow
administration of the vaccine during the 12 week period prior to radical
prostatectomy
– No invasive treatment for prostatic disease within the last 2 years
– Subject is free of clinically apparent/active autoimmune disease (no prior confirmed
diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis,
Grave’s Disease, Hashimoto’s Thyroiditis, Multiple Sclerosis, and Insulin Dependent
Diabetes Mellitus). Note subjects with Non-Insulin Dependent Diabetes Mellitus can be
included.
– Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count
(ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.
– Subject must practice a reliable form of contraception (barrier or vasectomy) while
they are being treated with vaccines and another effective method of birth control
must also be used by their partner
Exclusion Criteria:
– Diagnosis of any cancer other than prostate cancer within the last 5 years (except
basal cell carcinoma)
– Any suspicion of metastatic cancer
– Any Gleason grade 5 component in the prostatic biopsies
– Participation in another research study involving an investigational product in the
30 days preceding enrolment, or planned use during the study period
– Administration of immunoglobulins and/or any blood products within the three months
preceding the planned administration of the vaccine candidate
– Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV
– Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia,
recurrent, severe infections and chronic (more than 14 days) immunosuppressant
medication within the past 6 months (inhaled/topical steroids are allowed)
– Platelet count >400,000/μL; Monocytes >80,000/μL; Hemoglobin <11g/dL
– Known allergy to neomycin
– History of allergic response to previous vaccinia vaccinations
– History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine, e.g. egg products
– History of hypersensitivity and haemorrhagic cystitis
– Any history of anaphylaxis
– Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol
intake of greater than 42 units per week)
Participant Exclusion Criteria
This is in the inclusion criteria above

Trial Location(s)
University of Oxford
Oxford
OX3 7DQ
Royal Hallamshire Hospital
Sheffield
S10 2IF
Trial Contact(s)
Primary Trial Contact
Adrian Hill
adrian.hill@ndm.ox.ac.uk
+441865 857417
Other Trial Contacts
Irina Redchenko
irina.redchenko@ndm.ox.ac.uk
+441865 617623
Countries Recruiting
United KingdomScientific Title
A Randomized Phase I Study to Determine the Safety and Immunogenicity of ChAd-MVA Vaccination Compared to MVA Alone With and Without Low Dose Cyclophosphamide in Low and Intermediate Risk Localised Prostate Cancer
EudraCT Number
Not available for this trial
Funder(s)
Sorry, this information is not available
Other Study ID Numbers
VANCE01
Sponsor(s)
University of Oxford

To apply for this job please visit the following URL: http://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=29862 →