Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Study title: 
Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
EU record number: 
B/BE/11/BVW2
EudraCT number: 
2010-021196-85
Pharmaceutical study code: 
BNIT-PRV-301
Company / Sponsor: 
BN-Immunotherapeutics
Phase: 
III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Castrate-resistant prostate cancer
Therapeutic approach: 
Immunotherapy
Genetic modification: 
Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules
Method of transfer of nucleic acid of interest: 
Attenuated Vaccinia Virus (NYCBH Strain) + Attenuated Fowlpox Virus
Administered biological material: 
Recombinant Attenuated Vaccinia Virus + Recombinant Attenuated Fowlpox Virus
Route of administration: 
subcutaneous
Locations in Belgium: 
ZNA Middelheim, Antwerp - Cliniques St Luc, Brussels - Heilig Hart Ziekenhuis, Roeselaere - AZ Maria Middelares, Gent - UZ Gasthuisberg, Leuven - Institut Bordet, Brussels
Nr of subjects: 
1200 worldwide, 10 patients in Belgium
Foreseen duration: 
1 year
Type of procedure: 
Contained use and Deliberate release

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