Prostate CancerPhase 1NCT02390063
Vaccination in Prostate Cancer (VANCE)
A Phase 1 study testing ChAdOx1.5T4, MVA.5T4 and Cyclophosphamide in people with Prostate Cancer, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ChAdOx1.5T4, MVA.5T4 and Cyclophosphamide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2015to 15 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Oxford
Oxford, OX3 7DQ
Royal Hallamshire Hospital
Sheffield, S10 2IF
About this study
Official 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
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.
- Conditions
- Prostate Cancer
- Being tested
- ChAdOx1.5T4, MVA.5T4, Cyclophosphamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1.5T4Biological
A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
MVA.5T4Biological
A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
CyclophosphamideDrug
Also called CTX, CY, Cytoxan
Metronomic cyclophosphamide (50mg bd)
| Study group | Role | What they receive |
|---|---|---|
| CHAMVA standard regime | Experimental | ChAdOx1.5T4 prime followed by two boost of MVA.5T4 vaccine at 4 week intervals until radical prostatectomy Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4 |
| CHAMVA+CTX standard regime | Experimental | 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. Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4; Drug: Cyclophosphamide |
| MVA standard regime | Active comparator | Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy Receives: Biological: MVA.5T4 |
| MVA+CTX standard regime | Active comparator | One week of low dose cyclophosphamide pre-conditioning before each vaccination.Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy Receives: Biological: MVA.5T4; Drug: Cyclophosphamide |
| CHAMVA accelerated regime | Experimental | ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later until radical prostatectomy. Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4 |
| CHAMVA+CTX accelerated regime | Experimental | 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. Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4; Drug: Cyclophosphamide |
| CHAMVA accelerated regime AS | Experimental | ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later. Patients continue on active surveillance. Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4 |
| CHAMVA+CTX accelerated regime AS | Experimental | 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. Receives: Biological: ChAdOx1.5T4; Biological: MVA.5T4; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine safety and immunogenicity
Development or increase in anti-5T4 cellular and humoral responses in patients treated with CHAMVA or CHAMVA + CTX
Measured: Up to 52 weeks
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Participants will be followed for the duration of the study, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJun 2015
- Primary completion15 May 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Freddie Hamdy, Study chair, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390063
- Sponsor's protocol ID
- VANCE01
- Status last verified
- May 2018
- First submitted
- 10 Mar 2015
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32591433
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02390063
- Acronym / sponsor ID
- VANCE01
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| CHAMVA standard regime | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4ChAdOx1.5T4 prime followed by two boost of MVA.5T4 vaccine at 4 week intervals until radical prostatectomy |
| CHAMVA+CTX standard regime | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4, Drug: CyclophosphamideOne 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. |
| MVA standard regime | Active comparator | Biological: MVA.5T4Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy |
| MVA+CTX standard regime | Active comparator | Biological: MVA.5T4, Drug: CyclophosphamideOne week of low dose cyclophosphamide pre-conditioning before each vaccination.Three MVA.5T4 vaccinations at 4 week intervals until radical prostatectomy |
| CHAMVA accelerated regime | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later until radical prostatectomy. |
| CHAMVA+CTX accelerated regime | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4, Drug: CyclophosphamideOne 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. |
| CHAMVA accelerated regime AS | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4ChAdOx1.5T4 prime followed by one boost of MVA.5T4 one week later. Patients continue on active surveillance. |
| CHAMVA+CTX accelerated regime AS | Experimental | Biological: ChAdOx1.5T4, Biological: MVA.5T4, Drug: CyclophosphamideOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx1.5T4A recombinant simian adenovirus encoding human tumour-associated antigen 5T4 | Biological | CHAMVA accelerated regime, CHAMVA accelerated regime AS, CHAMVA standard regime, CHAMVA+CTX accelerated regime, CHAMVA+CTX accelerated regime AS, CHAMVA+CTX standard regime |
| MVA.5T4A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4 | Biological | CHAMVA accelerated regime, CHAMVA accelerated regime AS, CHAMVA standard regime, CHAMVA+CTX accelerated regime, CHAMVA+CTX accelerated regime AS, CHAMVA+CTX standard regime, MVA standard regime, MVA+CTX standard regime |
| CyclophosphamideAlso: CTX, CY, CytoxanMetronomic cyclophosphamide (50mg bd) | Drug | CHAMVA+CTX accelerated regime, CHAMVA+CTX accelerated regime AS, CHAMVA+CTX standard regime, MVA+CTX standard regime |
Primary outcome
Vaccine safety and immunogenicity
Time frame: Up to 52 weeks
Development or increase in anti-5T4 cellular and humoral responses in patients treated with CHAMVA or CHAMVA + CTX
5 secondary outcomes
Cellular and humoral immune response with CHAMVA
Time frame: Up to 52 weeks
Cellular and humoral immune response with MVA
Time frame: Up to 52 weeks
PSA level change secondary to vaccination
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
MRI or Gleason score change secondary to vaccination
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
Regulatory T-cell response
Time frame: Participants will be followed for the duration of the study, up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 32591433Cappuccini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddie Hamdy study chair
Oxford University Hospitals NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ChAdOx1.5T4, MVA.5T4 and Cyclophosphamide in people with Prostate Cancer, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine safety and immunogenicity (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.