SP017 (EudraCT number 2016-000567-16)
Research type
Research Study
Full title
A phase I/II study of neoadjuvant dendritic cell immunization(DCVAC/PCa) for organ-confined prostate cancer: tissue evaluation of immune infiltration into the primary tumours.
IRAS ID
201537
Contact name
Hardev Pandha
Contact email
Sponsor organisation
SOTIO a.s.
Eudract number
2016-000567-16
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The active cellular immunization DCVAC/PCa is an investigational medicinal product containing autologous dendritic cells (DCs) activated by ex vivo exposure to allogeneic prostate cancer cells. Data from phase I/II trials showed that it is able to induce or enhance specific immune responses against tumour-associated antigens in the peripheral blood. However, to date it is not known how these responses are translated into the tumour microenvironment. Therefore, this exploratory study aims at determining the degree of immune infiltration into the primary tumours and characterizing the tumour microenvironment following neoadjuvant administration of DCVAC/PCa in intermediate- and high-risk localized prostate cancer patients undergoing radical prostatectomy (RP). We hypothesize that neoadjuvant administration of DCVAC/PCa may modulate the presence of immune cells in the tumour and induce effector mechanisms able to eradicate tumour cells.
This study will be opened in the United Kingdom and the plan is to enrol up to 15 patients. The study population will consist of men with intermediate- and high-risk localized prostate cancer eligible to undergo radical prostatectomy. This is a single-arm (all patients will receive DCVAC/PCa), single-centre clinical trial. Each patient’s participation in the clinical trial is planned for approximately 70 weeks and will include following periods: Screening (this is done to find out if the patient can be enrolled in the study), Leukapheresis period, administration period, Radical prostatectomy, follow-up.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/2005
Date of REC Opinion
3 Feb 2017
REC opinion
Further Information Favourable Opinion