Study Results
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Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2015-06-30
2019-05-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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CHAMVA standard regime
ChAdOx1.5T4 prime followed by two boost of MVA.5T4 vaccine at 4 week intervals until radical prostatectomy
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
CHAMVA+CTX standard regime
One week of low dose cyclophosphamide pre-conditioning before each vaccination. ChAdOx1.5T4 prime followed by two boost of MVA.5T4 at 4 week intervals until radical prostatectomy.
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Cyclophosphamide
Metronomic cyclophosphamide (50mg bd)
MVA standard regime
Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
MVA+CTX standard regime
One week of low dose cyclophosphamide pre-conditioning before each vaccination.Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Cyclophosphamide
Metronomic cyclophosphamide (50mg bd)
CHAMVA accelerated regime
ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later until radical prostatectomy.
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
CHAMVA+CTX accelerated regime
One week of low dose cyclophosphamide pre-conditioning before each vaccination. ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later until radical prostatectomy.
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Cyclophosphamide
Metronomic cyclophosphamide (50mg bd)
CHAMVA accelerated regime AS
ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later. Patients continue on active surveillance.
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
CHAMVA+CTX accelerated regime AS
One week of low dose cyclophosphamide pre-conditioning before each vaccination. ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later. Patients continue on active surveillance.
ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Cyclophosphamide
Metronomic cyclophosphamide (50mg bd)
Interventions
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ChAdOx1.5T4
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
Cyclophosphamide
Metronomic cyclophosphamide (50mg bd)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
MALE
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Freddie Hamdy
Role: STUDY_CHAIR
Oxford University Hospitals NHS Trust
Locations
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University of Oxford
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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Cappuccini F, Bryant R, Pollock E, Carter L, Verrill C, Hollidge J, Poulton I, Baker M, Mitton C, Baines A, Meier A, Schmidt G, Harrop R, Protheroe A, MacPherson R, Kennish S, Morgan S, Vigano S, Romero PJ, Evans T, Catto J, Hamdy F, Hill AVS, Redchenko I. Safety and immunogenicity of novel 5T4 viral vectored vaccination regimens in early stage prostate cancer: a phase I clinical trial. J Immunother Cancer. 2020 Jun;8(1):e000928. doi: 10.1136/jitc-2020-000928.
Other Identifiers
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VANCE01
Identifier Type: -
Identifier Source: org_study_id
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