A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

Castration-resistant Prostate Cancer Clinical Trial

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.

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03514836
• Study type: Interventional
• Source: Sotio a.s.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 23, 2018
• Completion date: January 25, 2021