VAccination in Prostate caNCEr (VANCE) | Recruiting
VAccination in Prostate caNCEr (VAN... | Recruiting
VAccination in Prostate caNCEr (VANCE)

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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02390063
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 either decided to have their prostate removed or are stable on active surveillance.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : ChAdOx1.5T4, Biological : MVA.5T4, Drug : Cyclophosphamide

Study Arm Groups : CHAMVA standard regime, CHAMVA+CTX standard regime, CHAMVA accelerated regime, CHAMVA+CTX accelerated regime, CHAMVA accelerated regime AS, CHAMVA+CTX accelerated regime AS, CHAMVA standard regime, CHAMVA+CTX standard regime, MVA standard regime, MVA+CTX standard regime, CHAMVA accelerated regime, CHAMVA+CTX accelerated regime, CHAMVA accelerated regime AS, CHAMVA+CTX accelerated regime AS, CHAMVA+CTX standard regime, MVA+CTX standard regime, CHAMVA+CTX accelerated regime, CHAMVA+CTX accelerated regime AS

Intervention Type
See Interventions above
Primary Outcome Measures
    Vaccine safety and immunogenicity; Up to 52 weeks
Secondary Outcome Measures
    Cellular and humoral immune response with CHAMVA; Up to 52 weeks; Cellular and humoral immune response with MVA; Up to 52 weeks; PSA level change secondary to vaccination; Participants will be followed for the duration of the study, up to 52 weeks; MRI or Gleason score change secondary to vaccination; Participants will be followed for the duration of the study, up to 52 weeks; Regulatory T-cell response; Participants will be followed for the duration of the study, up to 52 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
48
Participant Inclusion Criteria
    Inclusion Criteria(Radical Prostatectomy patients):

    - Males aged 18 years and older

    - 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 ≤T2c

    - 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

    Inclusion Criteria (Active Surveillance patients)

    - Males aged 18 and older

    - 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 ≤T2c

    - No evidence of metastases (Nx/N0 and Mx/M0)

    - PSA ≤ 20 ng/ml

    - Stable disease on Active Surveillance for a minimum of 12 months previously

    - Suitable to remain on Active Surveillance at time of last clinical assessment

    - 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)

    - History of a serious psychiatric condition or other circumstance s that may be associated with not understanding or complying with the study protocol
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Oxford
OX3 7DQ
Royal Hallamshire Hospital
S10 2IF
Trial Contact(s)
Primary Trial Contact
Adrian Hill
+441865 857417
Other Trial Contacts
Irina Redchenko
+441865 617623
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
Key Dates

Recruitment Start Date

Jun 2015

Recruitment End Date

Mar 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 Mar 2015

Date updated in source

17 May 2017