Clinical trial to evaluate the safety and immune activation of DCVAC/PCa and ONCOS-102 in men with metastatic prostate cancer.
- Conditions
- advanced metastatic castration-resistant prostate cancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004314-15-CZ
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 15
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 <1.5×ULN *
*If the patient has liver metastases, these parameters might not be applicable and the decision on inclusion of the patient into the study is to be made by the Investigator after discussion with the Sponsor’s Medical Monitor.
9. 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
10. Life expectancy of at least 12 months based on the Investigator’s judgement
11. Signed Informed Consent Form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•To evaluate radiographic progression-free survival by radiographic evidence of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1<br>•To evaluate overall survival<br>•To evaluate the objective response rate<br>;Primary end point(s): Safety profile as measured by adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and vital signs<br>;Timepoint(s) of evaluation of this end point: after the last visit of the last patient enrolled in the clinical trial.
- Secondary Outcome Measures
Name Time Method 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<br>•Radiographic progression-free survival (per RECIST v 1.1), a composite of: <br>oradiographic progression of bone lesions<br>oradiographic progression of soft tissue lesions<br>odeath due to any cause<br>•Overall survival<br>•Objective response rate (per RECIST v 1.1)<br>;Timepoint(s) of evaluation of this end point: after the last visit of the last patient enrolled in the clinical trial.