VAccination in early and ADvanced prostate caNCEr (ADVANCE)
Research type
Research Study
Full title
Phase II open label 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
IRAS ID
236878
Contact name
Mark Tuthill
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-001992-22
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study (funded by EC FP7 grant) is investigating a combination of novel anti-cancer vaccines and a new class of immune therapy medicines, known as checkpoint inhibitors, as a treatment for prostate cancer. This is a study in early stage and advanced metastatic prostate cancer patients to assess the safety and efficacy of the novel prostate cancer vaccine in combination with a checkpoint inhibitor nivolumab. Patients for this study will be recruited and treated at 3 clinical sites across the UK and one site in Switzerland. The early stage prostate cancerpatients will receive two injections of a tumour antigen 5T4, the first delivered by adenovirus (ChAd) and the second by modified vaccinia ankara (MVA), given one week apart. Then they will undergo surgery to have their prostate removed at least 4 weeks after the second vaccination. Advanced prostate cancer patients will have a second cycle of ChAD-MVA vaccines given 2 months after the last immunisation. Nivolumab will be given only once to surgical patients – with the MVA vaccine; metastatic cancer patients will receive 3 infusions of nivolumab 4 weeks apart, the first infusion with the first MVA vaccine and the last – with the second ChAd vaccine. The patients will be on the study for 6 months (surgical patients) or 12 months (metastatic cancer patients). Throughout the study a number of blood samples will be collected to perform various tests for the treatment efficacy assessment.
There is a possibility that this combinatorial treatment may delay the recurrence, progression or spread of prostate cancer. Additionally, the patients will benefit from extra medical care during the study. Ultimately, this study will be contributing towards research on developing new treatments for prostate cancer.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0004
Date of REC Opinion
6 Feb 2018
REC opinion
Further Information Favourable Opinion