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Trial record 1 of 6 for:    ONCOS-102
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A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514836
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE May 23, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Progression Free Survival [ Time Frame: 96 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Overall Survival [ Time Frame: 96 months ]
    Defined as the time from Baseline visit to the date of death for any cause
  • Safety [ Time Frame: 96 months ]
    Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033
  • Time to Progression-PSA [ Time Frame: 96 months ]
    demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2
  • Radiographic Progression- free survival [ Time Frame: 96 months ]
    composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label combination treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Castration-resistant Prostate Cancer
Intervention  ICMJE
  • Biological: DCVac/PCa
    Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy
    Other Name: ONCOS-102
  • Drug: Cyclophosphamide
    immunomodulatory medication given around the ONCOS-102 dosing
Study Arms  ICMJE Experimental: DCVac and ONCOS-102
ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses
Interventions:
  • Biological: DCVac/PCa
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Prostate Cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Richard Kapsa (+420) 2241 74448 kapsa@sotio.com
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514836
Other Study ID Numbers  ICMJE SP015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sotio a.s.
Study Sponsor  ICMJE Sotio a.s.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Inna Krasnopolskaya, MD Sotio as
PRS Account Sotio a.s.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP