Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03815942
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2019-01-04
Brief Title:
VAccination in Early and ADvanced Prostate caNCEr
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Phase III 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
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCE
Brief 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 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 bodys 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None