A Phase 1/2 interventional study of DCVac/PCa and Cyclophosphamide in Castration-resistant Prostate Cancer, sponsored by SOTIO a.s.. Terminated at 1 site in Czechia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by SOTIO a.s. · Phase 1/2, Interventional, and Treatment
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:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 5 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →SOTIO a.s. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses
Biological: DCVac/PCa · Drug: Cyclophosphamide
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.
Also known as: ONCOS-102
immunomodulatory medication given around the ONCOS-102 dosing
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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SOTIO a.s.