A phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer.

SOTIO a.s.0 sites15 target enrollmentJune 21, 2016

Overview

No summary available.

Registry

who.int

Start Date

June 21, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

SOTIO a.s.

•1\. Males 18 years of age and older
•2\. Histologically or cytologically confirmed adenocarcinoma of the prostate
•3\. Radiographically documented metastatic disease (presence of skeletal or soft\-tissue/visceral/nodal metastases) with evidence of disease according to the following criteria:
•\- Measurable lymph nodes (short axis \= 15 mm) or visceral lesion measurable per RECIST v 1\.1 or
•\- Two or more lesions on bone scan/imaging and with at least one soft tissue or visceral lesion being accessible for intratumoral administration of ONCOS\-102 and biopsy.
•4\. ECOG performance status 0\-1
•5\. PSA \=2 ng/mL
•6\. Rising PSA levels after previous treatment failure.
•7\. Surgically or medically castrate with serum testosterone levels \=1\.7 nmol/L. Patients who have not had bilateral orchiectomy must be maintained on standard dosing of GnRH/LHRH analog therapy at appropriate frequency for the duration of the clinical trial.
•8\. Laboratory criteria:

•1\.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
•3\.Systemic immunosuppressive therapy apart from corticosteroids at a dose of less than 10 mg/day
•4\.Administration of experimental therapy within the last 4 weeks before start of screening
•5\.Treatment with immunotherapy within the last 3 months before start of screening
•6\.Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
•7\.Patient significant co\-morbidities (cardiovascular diseases, eg, unstable angina pectoris, uncontrolled hypertension, myocardial infarction, ventricular arrhythmia, or stroke within a 6\-month period before the Baseline visit; congestive heart failure or cardiac arrhythmia not controlled by treatment; active severe infections; uncontrolled metabolic disorders; etc.)
•8\.Known hypersensitivity or allergic reaction (other than local inflammatory reaction or irritation at injection site) to DCVAC/PCa or its constituents, ie, CryoStor CS10 freeze medium (Biolife Solutions) containing 10% dimethyl sulfoxide
•9\.Uncontrolled co\-morbidities including social conditions which in the Investigator’s opinion would prevent participation in/completion of the clinical trial
•10\.Patients known to be HIV positive or syphilitic