A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03514836|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : June 12, 2018
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|
|Castration-resistant Prostate Cancer||Biological: DCVac/PCa Drug: Cyclophosphamide||Phase 1 Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label combination treatment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
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
Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy
Other Name: ONCOS-102
immunomodulatory medication given around the ONCOS-102 dosing
- Progression Free Survival [ Time Frame: 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.
- Overall Survival [ Time Frame: 96 months ]Defined as the time from Baseline visit to the date of death for any cause
- Safety [ Time Frame: 96 months ]Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033
- Time to Progression-PSA [ Time Frame: 96 months ]demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2
- Radiographic Progression- free survival [ Time Frame: 96 months ]composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514836
|Contact: Richard Kapsa||(+420) 2241 firstname.lastname@example.org|
|Fakultní nemocnice v Motole||Recruiting|
|Praha, Czechia, 150 06|
|Study Director:||Inna Krasnopolskaya, MD||Sotio as|