SP015:Combination of DCVAC/PCa and ONCOS-102 in mCRPC
Research type
Research Study
Full title
A phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer.
IRAS ID
210719
Contact name
Hardev Pandha
Contact email
Sponsor organisation
SOTIO a.s.
Eudract number
2015-004314-15
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The main purpose of this study is to find out if it is safe to use the combination of investigational (experimental) drugs called DCVAC/PCa and ONCOS-102 for the treatment of advanced prostate cancer.
ONCOS-102 (CGTG-102) is a genetically modified virus with cancer killing properties. The treatment with this virus will be combined with a vaccine made from the patients own blood. The virus has been used safely in a trial in Finland.
The clinical trial will be opened in the United Kingdom and the Czech Republic. In total, 15 patients will be enrolled in the clinical trial (up to 10 in the UK). The virus ONCOS-102 will be injected directly into patient tumor weekly for one month (week 5,6,7,8) and then additionally 2 doses will be given in week 14-23. The vaccine,DCVAC/PCa, will be injected into the skin over a 3-week period (week 8, 11 and 14) and then every 6 weeks up to 10 doses.The proposed release will be conducted at Surrey Cancer Research Institute, Faculty of Health and Medical Sciences, University of Surrey, National Grid Reference SU973497) between 3rd quarter 2016 and 3rd quarter of 2018.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0003
Date of REC Opinion
27 Jan 2017
REC opinion
Unfavourable Opinion