This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy. Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.
Study Description: * All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. * ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis * Cyclophosphamide A priming bolus dose of CPO (300 mg/m2 intravenously) will be given 1-3 days before the first (Week 5) and the fifth (Week 14) of ONCOS-102 administration. * DCVAC/PCa therapy will start 6 weeks after leukapheresis at Week 8. DCVAC/PCa will be administered subcutaneously in cycles, always on Day 1 (+/- 3 days) of the corresponding cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy. DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.
immunomodulatory medication given around the ONCOS-102 dosing
Fakultní nemocnice v Motole
Prague, Czechia
Progression Free Survival
PFS measured by modifications to the RECIST 1.1. PFS is defined as the time from the first dose of SoC therapy administered to tumor progression or death from any cause.
Time frame: 96 months
Overall Survival
Defined as the time from Baseline visit to the date of death for any cause
Time frame: 96 months
Safety
Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033
Time frame: 96 months
Time to Progression-PSA
demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2
Time frame: 96 months
Radiographic Progression- free survival
composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause
Time frame: 96 months
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