Clinical trial NCT03514836: A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Castration-resistant Prostate Cancer
Keywords: Castrate-resistant
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-02
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label combination treatment
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 96 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 96 months
measure: Safety
timeFrame: 96 months
measure: Time to Progression-PSA
timeFrame: 96 months
measure: Radiographic Progression- free survival
timeFrame: 96 months
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Fakultní nemocnice v Motole
Study officials:
affiliation: Sotio as
name: Roman Korolkiewicz, MD, PhD
role: STUDY_DIRECTOR
References: