Intermediate Risk Prostate CancerPhase 1/2ADVANCENCT03815942
VAccination in Early and ADvanced Prostate caNCEr
A Phase 1/2 study testing ChAdOx1-MVA 5T4 vaccine and Nivolumab Infusion [Opdivo] in people with Intermediate Risk Prostate Cancer and Castration-resistant 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
- Intermediate Risk Prostate Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- ChAdOx1-MVA 5T4 vaccine and Nivolumab Infusion [Opdivo]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Dec 2018to 24 Jun 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For all participants:
- Histologically confirmed adenocarcinoma of the prostate cancer
- Any antineoplastic therapy must have been completed a minimum of 28 days prior to enrolment
- Systemic antimicrobial therapy must have been completed a minimum of 7 days prior to enrolment
- An archival specimen of tumour tissue should be available
- Baseline laboratory parameters must meet the following criteria:
Show all 17Show fewer
- Haemoglobin ≥ 80 g/L, White cell count ≥ 2.0 x10^9/L, Neutrophils ≥ 1.5 x10^9/L, Lymphocytes ≥ 0.5 x10^9/L, Platelets ≥ 100 x10^9/L, Creatinine Clearance ≥ 40 ml/min by Cockcroft Gault formulation, Total Bilirubin ≤ 1.5 ULN, Alanine Aminotransferase ≤ 1.5 ULN, Amylase ≤ 1.5 ULN
- For surgical cohort:
- Clinically localised or locally advanced disease deemed operable by the treating consultant urological surgeon i.e.: Gleason score ≤ 7, local tumour stage ≤T3c and deemed operable, no evidence of metastases (Nx/N0 and Mx/M0), no evidence of high grade Gleason 5 disease, PSA ≤ 20 ng/ml
- Scheduled for and considered fit for radical prostatectomy
- For advanced metastatic cohort:
- Evidence of at least one distant metastasis based on MRI, CT, PET or bone scintigraphy
- Established on and suitable to continue with androgen deprivation therapy (ADT) using any luteinizing hormone releasing hormone (LHRH) agonist
- On treatment with anti-androgen therapy using either abiraterone (Zytiga®) or enzalutamide (Xtandi®) and demonstrating evidence of disease progression at the time of enrolment
- Suitable to continue therapy with either abiraterone or enzalutamide at the time of enrolment at discretion of their managing clinician
- Patients who have received chemotherapy following progression on androgen-targeting therapies are eligible
- Satisfactory functional status defined as ECOG Performance Status ≤ 1
Who cannot join
- For all participants:
- Any prior diagnosis or clinical suspicion of autoimmune disease
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, e.g. egg products
- Other prior malignancy with an estimated ≥ 30% chance of relapse within 2 years
- Participation in another research study involving an investigational product or investigational surgical procedure in the 30 days preceding enrolment, or planned use during the study period
- Any prior exposure to checkpoint inhibitor drugs including anti-PD-1, anti-PD-L1, or anti-CTLA-4 monoclonal antibodies or any prior treatment with investigational vaccines
Show all 15Show fewer
- Administration of immunoglobulins and/or any blood products within the one month preceding the planned administration of the study drugs
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Any confirmed or suspected immunocompromised state
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema
- History of anaphylaxis in relation to vaccination or any clinically significant allergic disease likely to be exacerbated by any component of the vaccine or checkpoint inhibitor preparations
- For advanced metastatic cohort:
- The treating oncologist estimates a subject's life expectancy to be ≤ 6 months
- Any active, previously treated, or suspected intracranial or leptomeningeal metastases
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Oncology, The Christie NHS Foundation Trust
Manchester, M20 4BX
Cancer and Haematology Centre, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
About this study
Official title: Phase I/II Open Label Non-randomised Safety and Efficacy Study of the Viral Vectored ChAd-MVA 5T4 Vaccine in Combination With PD-1 Checkpoint Blockade in Low- or Intermediate-risk Localized or Locally Advanced Prostate Cancer and Advanced Metastatic 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"- chimpanzee adenovirus Ox1 and "MVA" - modified vaccinia Ankara) 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 vaccine will be used in combination with the immunotherapy drug called nivolumab which is an anti-PD-1 (Programmed Death protein-1) monoclonal antibody. This is a molecule that releases the brakes on the immune system and helps the immune system to kill cancer cells more efficiently. Nivolumab as a monotherapy was approved for treatment of several tumour types but not for the prostate cancer.
This study will evaluate the safety and efficacy of ChAdOx1-MVA 5T4 vaccine in combination with nivolumab in low and intermediate risk prostate cancer patients who have elected to have their prostate removed and in patients with advanced metastatic prostate cancer.
Read the detailed description
The purpose of this study was to evaluate the safety and efficacy of a combination of two new vaccines (ChAdOx1.5T4 and MVA.5T4) with a monoclonal antibody (PD-1 mAb, also known as Nivolumab and Opdivo®) against Prostate Cancer.
A vaccine that alerts 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 use of two different forms of the vaccine has been shown to generate a more effective immune response.
ChAdOx1.5T4 consists of a virus (ChAdOx1), which is a weakened version of a chimpanzee adenovirus that has been genetically altered so that it is impossible for it to grow in humans. Modified Vaccinia virus Ankara (MVA) is licensed as third-generation vaccine against smallpox and serves as a potent vector system for development of new candidate vaccines against infectious diseases and cancer.
To both viruses we have added genes that make the 5T4 protein that is present in prostate cancer cells and which is essential to the cancer. By vaccinating, we are hoping to make the body recognise and develop an immune response to these proteins that will neutralise the effects of the cancer in human cells and therefore prevent the infection responsible for the disease.
Nivolumab (PD-1 mAb) is an immune checkpoint inhibitor. Immune checkpoints are a normal part of the immune system. Their role is to prevent an immune response from being so strong that it destroys healthy cells in the body. Immune checkpoints engage when proteins on the surface of immune cells called T cells recognize and bind to partner proteins on other cells, such as some tumour cells. These proteins are called immune checkpoint proteins. When the checkpoint and partner proteins bind together, they send an "off" signal to the T cells. This can prevent the immune system from destroying the cancer. Immunotherapy drugs called immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the "off" signal from being sent, allowing the T cells to kill the cancer cells. Nivolumab as a monotherapy has been approved for treatment of several tumour types but not currently for prostate cancer.
The intent was to have two cohorts of participants: Group 1 were patients who had been diagnosed with low- or intermediate-risk non-metastatic prostate adenocarcinoma and who were scheduled for radical prostatectomy; Group 2 comprised patients with metastatic castration resistant prostate cancer (mCRPC) with evidence of progression on anti-androgens.
Unfortunately, it proved impossible to recruit participants into Group 1, so the trial proceeded with just Group 2.
It was planned that the results would be measured by a composite response rate defined as one of the following:
- reduction of circulating tumour DNA of ≥50%
- serum PSA decrease of ≥50%
However, the analysis to measure the circulating tumour DNA (ctDNA) was not done for any of the participants due to the trial ending prematurely because of the COVID-19 pandemic in 2020.
The trial and the follow-up of participants was severely hampered by the Covid-19 pandemic.
In this study, we have shown that the candidate 5TA vaccines given were safe and well-tolerated. No serious adverse reactions occurred during the follow-up period. Most adverse events reported were mild or moderate in severity and all resolved spontaneously. The profile of adverse events reported in this trial is similar to other ChAdOx1 vectored vaccines.
- Being tested
- ChAdOx1-MVA 5T4 vaccine, Nivolumab Infusion [Opdivo]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1-MVA 5T4 vaccineBiological
ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10^8 plaque forming units
Nivolumab Infusion [Opdivo]Drug
Also called anti-PD-1 monoclonal antibody
Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Intermediate risk prostate cancer | Experimental | ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6. Receives: Biological: ChAdOx1-MVA 5T4 vaccine; Drug: Nivolumab Infusion [Opdivo] |
| Advanced metastatic prostate cancer | Experimental | ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12. Receives: Biological: ChAdOx1-MVA 5T4 vaccine; Drug: Nivolumab Infusion [Opdivo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Incidence of Treatment-related Adverse Events.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Note: All participants had one or more adverse events during the period they were monitored.
Measured: From baseline to 12 months
Efficacy - Measure Composite Response Rate Defined as One of the Following: 1) Change in Circulating Tumour DNA 2) Change in Serum PSA
Evaluate the efficacy by assessing the number of participants with 50% or more change in ctDNA or PSA concentration in the blood from baseline to 12 months post treatment.
Change in serum PSA was analysed for this outcome as one the two alternative methods planned.
As described in the trial overview, no ctDNA analysis was done due to the trial closing prematurely because of COVID-19 - by the time the pandemic had finished, the facility to perform the ctDNA analysis option was no longer available. Because no laboratory analysis was done, there is no data to report.
Measured: From baseline to 12 months
Secondary outcomes (4)
Evaluate Immune Responses to the Vaccine Antigen in the Periphery
Number of participants with peripheral 5T4-specific T cell responses secondary to treatment
Measured: From baseline to 12 months
Evaluate Immune Cell Subsets in the Prostate Secondary to Treatment (for Surgical Cohort)
Number of participants with intraprostatic infiltration of CD3+CD8+ T cells secondary to treatment
Measured: From baseline to radical prostatectomy, an expected average of 6 weeks
Evaluate Progression-free Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
Evaluating the number of participants experiencing progression-free survival at 6 and 12 months post treatment
Measured: 6-12 months
Evaluate Overall Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
Evaluating the number of participants experiencing overall survival at 6 and 12 months post treatment
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start10 Dec 2018
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Why it stopped: COVID stopped all trials - and ADVANCE could not restart again after the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermediate Risk 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Barinthus Biotherapeutics
- Responsible party
- Sponsor
- Investigators
- Adrian VS Hill, Study director, University of OxfordFreddie Hamdy, Study director, Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation TrustAndrew Protheroe, Principal investigator, Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation TrustPeter Hoskin, Principal investigator, Department of Oncology, The Christie NHS Foundation TrustMark Tuthill, Study chair, Oxford Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815942
- Sponsor's protocol ID
- ADVANCE
- Acronym
- ADVANCE
- Status last verified
- Jun 2025
- First submitted
- 4 Jan 2019
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results in anonymised summary will be shared in publications resulting from the trial.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open Label Non-randomised Safety and Efficacy Study of the Viral Vectored ChAd-MVA 5T4 Vaccine in Combination With PD-1 Checkpoint Blockade in Low- or Intermediate-risk Localized or Locally Advanced Prostate Cancer and Advanced Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03815942
- Acronym / sponsor ID
- ADVANCE / ADVANCE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID stopped all trials - and ADVANCE could not restart again after the pandemic
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Barinthus Biotherapeutics
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 25 Jun 2025
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"- chimpanzee adenovirus Ox1 and "MVA" - modified vaccinia Ankara) 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 vaccine will be used in combination with the immunotherapy drug called nivolumab which is an anti-PD-1 (Programmed Death protein-1) monoclonal antibody. This is a molecule that releases the brakes on the immune system and helps the immune system to kill cancer cells more efficiently. Nivolumab as a monotherapy was approved for treatment of several tumour types but not for the prostate cancer.
This study will evaluate the safety and efficacy of ChAdOx1-MVA 5T4 vaccine in combination with nivolumab in low and intermediate risk prostate cancer patients who have elected to have their prostate removed and in patients with advanced metastatic prostate cancer.
Detailed description
The purpose of this study was to evaluate the safety and efficacy of a combination of two new vaccines (ChAdOx1.5T4 and MVA.5T4) with a monoclonal antibody (PD-1 mAb, also known as Nivolumab and Opdivo®) against Prostate Cancer.
A vaccine that alerts 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 use of two different forms of the vaccine has been shown to generate a more effective immune response.
ChAdOx1.5T4 consists of a virus (ChAdOx1), which is a weakened version of a chimpanzee adenovirus that has been genetically altered so that it is impossible for it to grow in humans. Modified Vaccinia virus Ankara (MVA) is licensed as third-generation vaccine against smallpox and serves as a potent vector system for development of new candidate vaccines against infectious diseases and cancer.
To both viruses we have added genes that make the 5T4 protein that is present in prostate cancer cells and which is essential to the cancer. By vaccinating, we are hoping to make the body recognise and develop an immune response to these proteins that will neutralise the effects of the cancer in human cells and therefore prevent the infection responsible for the disease.
Nivolumab (PD-1 mAb) is an immune checkpoint inhibitor. Immune checkpoints are a normal part of the immune system. Their role is to prevent an immune response from being so strong that it destroys healthy cells in the body. Immune checkpoints engage when proteins on the surface of immune cells called T cells recognize and bind to partner proteins on other cells, such as some tumour cells. These proteins are called immune checkpoint proteins. When the checkpoint and partner proteins bind together, they send an "off" signal to the T cells. This can prevent the immune system from destroying the cancer. Immunotherapy drugs called immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the "off" signal from being sent, allowing the T cells to kill the cancer cells. Nivolumab as a monotherapy has been approved for treatment of several tumour types but not currently for prostate cancer.
The intent was to have two cohorts of participants: Group 1 were patients who had been diagnosed with low- or intermediate-risk non-metastatic prostate adenocarcinoma and who were scheduled for radical prostatectomy; Group 2 comprised patients with metastatic castration resistant prostate cancer (mCRPC) with evidence of progression on anti-androgens.
Unfortunately, it proved impossible to recruit participants into Group 1, so the trial proceeded with just Group 2.
It was planned that the results would be measured by a composite response rate defined as one of the following:
- reduction of circulating tumour DNA of ≥50%
- serum PSA decrease of ≥50%
However, the analysis to measure the circulating tumour DNA (ctDNA) was not done for any of the participants due to the trial ending prematurely because of the COVID-19 pandemic in 2020.
The trial and the follow-up of participants was severely hampered by the Covid-19 pandemic.
In this study, we have shown that the candidate 5TA vaccines given were safe and well-tolerated. No serious adverse reactions occurred during the follow-up period. Most adverse events reported were mild or moderate in severity and all resolved spontaneously. The profile of adverse events reported in this trial is similar to other ChAdOx1 vectored vaccines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate risk prostate cancer | Experimental | Biological: ChAdOx1-MVA 5T4 vaccine, Drug: Nivolumab Infusion [Opdivo]ChAdOx1.5T4 on week 0 followed by booster injection of MVA.5T4 and nivolumab infusion on week 1. Patients will undergo radical prostatectomy on week 6. |
| Advanced metastatic prostate cancer | Experimental | Biological: ChAdOx1-MVA 5T4 vaccine, Drug: Nivolumab Infusion [Opdivo]ChAdOx1.5T4 on week 0 followed by booster injections of MVA.5T4 on week 4, ChAdOx1.5T4 on week 12 and MVA.5T4 on week 16. Nivolumab infusions are to be administered on week 4, 8 and 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed adenocarcinoma of the prostate cancer
- Any antineoplastic therapy must have been completed a minimum of 28 days prior to enrolment
- Systemic antimicrobial therapy must have been completed a minimum of 7 days prior to enrolment
- An archival specimen of tumour tissue should be available
- Baseline laboratory parameters must meet the following criteria:
Key exclusion criteria (15 listed)
- Any prior diagnosis or clinical suspicion of autoimmune disease
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, e.g. egg products
- Other prior malignancy with an estimated ≥ 30% chance of relapse within 2 years
- Participation in another research study involving an investigational product or investigational surgical procedure in the 30 days preceding enrolment, or planned use during the study period
- Any prior exposure to checkpoint inhibitor drugs including anti-PD-1, anti-PD-L1, or anti-CTLA-4 monoclonal antibodies or any prior treatment with investigational vaccines
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-MVA 5T4 vaccineChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10^8 plaque forming units | Biological | Advanced metastatic prostate cancer, Intermediate risk prostate cancer |
| Nivolumab Infusion [Opdivo]Also: anti-PD-1 monoclonal antibodyNivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion | Drug | Advanced metastatic prostate cancer, Intermediate risk prostate cancer |
Primary outcome
Safety - Incidence of Treatment-related Adverse Events.
Time frame: From baseline to 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Note: All participants had one or more adverse events during the period they were monitored.
Efficacy - Measure Composite Response Rate Defined as One of the Following: 1) Change in Circulating Tumour DNA 2) Change in Serum PSA
Time frame: From baseline to 12 months
Evaluate the efficacy by assessing the number of participants with 50% or more change in ctDNA or PSA concentration in the blood from baseline to 12 months post treatment. Change in serum PSA was analysed for this outcome as one the two alternative methods planned. As described in the trial overview, no ctDNA analysis was done due to the trial closing prematurely because of COVID-19 - by the time the pandemic had finished, the facility to perform the ctDNA analysis option was no longer available. Because no laboratory analysis was done, there is no data to report.
4 secondary outcomes
Evaluate Immune Responses to the Vaccine Antigen in the Periphery
Time frame: From baseline to 12 months
Evaluate Immune Cell Subsets in the Prostate Secondary to Treatment (for Surgical Cohort)
Time frame: From baseline to radical prostatectomy, an expected average of 6 weeks
Evaluate Progression-free Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
Time frame: 6-12 months
Evaluate Overall Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
Time frame: 6-12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The results in anonymised summary will be shared in publications resulting from the trial.
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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.
Adrian VS Hill study director
University of Oxford
Freddie Hamdy study director
Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust
Andrew Protheroe principal investigator
Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx1-MVA 5T4 vaccine and Nivolumab Infusion [Opdivo] in people with Intermediate Risk Prostate Cancer and Castration-resistant 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 17 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: stopped early, as of the sponsor's last update on 25 Jun 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety - Incidence of Treatment-related Adverse Events. (time frame: From baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.