Castration-resistant Prostate Cancer
Conditions
Keywords
Castrate-resistant
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALDCVac/PCa
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.
DRUGCyclophosphamide
immunomodulatory medication given around the ONCOS-102 dosing
Sponsors
SOTIO a.s.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label combination treatment
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate * Radiographically documented metastatic disease with evidence of disease progression Laboratory parameters per protocol * Surgically or medically castrate * Patients who have progressed following: * a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or * b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or * c. failure of two lines of chemotherapy; or * d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy
Exclusion criteria
* Patients with neuroendocrine or small cell cancer of the prostate 2. History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years Pre-defined co-morbidities * Administration of experimental therapy within the last 4 weeks before start of screening * Treatment with immunotherapy within the last 3 months before start of screening * Treatment with radiopharmaceutical drugs within 8 weeks before start of screening * Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start * History of organ transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 96 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 96 months | Defined as the time from Baseline visit to the date of death for any cause |
| Safety | 96 months | Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033 |
| Time to Progression-PSA | 96 months | demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2 |
| Radiographic Progression- free survival | 96 months | composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause |
Countries
Czechia
Outcome results
None listed