NCT03514836

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

April 11, 2018

Last Update Submit

January 27, 2021

Conditions

Castration-resistant Prostate Cancer

Keywords

Castrate-resistant

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    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.

    96 months

Secondary Outcomes (4)

  • Overall Survival

    96 months

  • Safety

    96 months

  • Time to Progression-PSA

    96 months

  • Radiographic Progression- free survival

    96 months

Study Arms (1)

DCVac and ONCOS-102

EXPERIMENTAL

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

Biological: DCVac/PCaDrug: Cyclophosphamide

Interventions

DCVac/PCaBIOLOGICAL

Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy. DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.

Also known as: ONCOS-102
DCVac and ONCOS-102
CyclophosphamideDRUG

immunomodulatory medication given around the ONCOS-102 dosing

DCVac and ONCOS-102

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fakultní nemocnice v Motole

Prague, 150 06, Czechia

Location

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Roman Korolkiewicz, MD, PhD

    Sotio as

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label combination treatment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

May 2, 2018

Study Start

May 23, 2018

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CZ(1)