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COVID stopped all trials - and ADVANCE could not restart again after the pandemic
ADVANCE
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
Sponsor study identifier
interventional
23
1 country
2
Study Start
December 10, 2018
Actual (reported)Primary Completion
June 24, 2020
Actual (reported)Study Completion
June 24, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 24, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2018
Actual (reported)January 4, 2019
Actual (reported)January 24, 2019
Actual (reported)June 24, 2020
Actual (reported)June 24, 2020
Actual (reported)June 25, 2025
Actual (reported)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.
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.
From baseline to 12 months
Evaluate Immune Responses to the Vaccine Antigen in the Periphery
From baseline to 12 months
Evaluate Immune Cell Subsets in the Prostate Secondary to Treatment (for Surgical Cohort)
From baseline to radical prostatectomy, an expected average of 6 weeks
Evaluate Progression-free Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
6-12 months
Evaluate Overall Survival Following Study Treatment (for Advanced Metastatic Cancer Cohort)
6-12 months
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.
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.
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 is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
Department of Oncology, The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Cancer and Haematology Centre, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
The trial finished prematurely due to the COVID-19 pandemic in 2020.
Adrian VS Hill
University of Oxford
Freddie Hamdy
Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust
Andrew Protheroe
Nuffield Department of Surgical Sciences, Oxford University Hospitals NHS Foundation Trust
Peter Hoskin
Department of Oncology, The Christie NHS Foundation Trust
23 participants (actual enrollment reported by the registry).
First Submitted
January 4, 2019
First Posted
January 24, 2019
Study Start
December 10, 2018
Actual (reported)Contact the study team to confirm eligibility.
Mark Tuthill
Oxford Cancer and Haematology Centre, Oxford University Hospitals NHS Foundation Trust
Primary Completion
June 24, 2020
Actual (reported)Study Completion
June 24, 2020
Actual (reported)Last Updated
June 25, 2025
Results First Posted
June 25, 2025
Record last verified: 2025-06
The results in anonymised summary will be shared in publications resulting from the trial.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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