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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03514836
• Other study ID #: SP015
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 23, 2018
• Est. completion date: January 25, 2021

Study information

• Verified date: January 2021
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Drug:
• Cyclophosphamide
immunomodulatory medication given around the ONCOS-102 dosing

Locations

Country	Name	City	State
Czechia	Fakultní nemocnice v Motole	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	96 months
Secondary	Overall Survival	Defined as the time from Baseline visit to the date of death for any cause	96 months
Secondary	Safety	Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033	96 months
Secondary	Time to Progression-PSA	demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2	96 months
Secondary	Radiographic Progression- free survival	composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause	96 months