A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCVac and ONCOS-102 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
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.
Other Names:
Drug: Cyclophosphamide
immunomodulatory medication given around the ONCOS-102 dosing
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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:
-
- at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or
-
- one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or
-
- failure of two lines of chemotherapy; or
-
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fakultní nemocnice v Motole | Praha | Czechia | 150 06 |
Sponsors and Collaborators
- SOTIO a.s.
Investigators
- Study Director: Roman Korolkiewicz, MD, PhD, Sotio as
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP015