advanced metastatic castration-resistant prostate cancer MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DCVAC/PCa
Product Code: DCVAC/PCa
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DCVAC/PCa
Current Sponsor code: DCVAC/PCa
Other descriptive name: CELL SUSPENSION CON
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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: a. White blood cell count (WBC) greater than 4,000/mm3 (4.0×109/L) b. Platelet count of at least 100,000/mm3 (100×109/L) c. Total bilirubin within normal limits (benign hereditary hyper-bilirubinemias, eg, Gilbert’s syndrome, are permitted)* d. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion 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 11. Known active (infectious) hepatitis B and active hepatitis C 12. Known central nervous malignancies such as glioma and brain metastases 13. Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start 14. History of organ transplantation 15. Any autoimmune diseases, therapies with monoclonal antibodies, any psychiatric disease, medical history of active TBC and any allogeneic stem cell transplantations in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 primed with cyclophosphamide (CPO) in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormonal manipulation (eg,abiraerone and enzalutamide) or chemotherapy;Secondary Objective: • To evaluate time to disease progression demonstrated by prostate-specific antigen (PSA) levels • To evaluate radiographic progression-free survival by radiographic evidence of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 • To evaluate overall survival • To evaluate the objective response rate ;Primary end point(s): Safety profile as measured by adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and vital signs ;Timepoint(s) of evaluation of this end point: after the last visit of the last patient enrolled in the clinical trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to PSA progression demonstrated by a rising PSA value as defined by the Prostate Cancer Working Group 2, ie, 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir, which is confirmed by a second value (also 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir) obtained 3 to 6 weeks later • Radiographic progression-free survival (per RECIST v 1.1), a composite of: o radiographic progression of bone lesions o radiographic progression of soft tissue lesions o death due to any cause • Overall survival • Objective response rate (per RECIST v 1.1) ;Timepoint(s) of evaluation of this end point: after the last visit of the last patient enrolled in the clinical trial. | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trial SOTIO
SOTIO a.s.
Outcome results
None listed