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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

Primary Purpose

Castration-resistant Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

Czechia

Study Type

Interventional

Intervention

DCVac/PCa

Cyclophosphamide

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring Castrate-resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Fakultní nemocnice v Motole

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCVac and ONCOS-102

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Defined as the time from Baseline visit to the date of death for any cause

Safety

Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033

Time to Progression-PSA

demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2

Radiographic Progression- free survival

composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause

Full Information

NCT ID

NCT03514836

First Posted

April 11, 2018

Last Updated

January 27, 2021

Sponsor

SOTIO a.s.

1. Study Identification

Unique Protocol Identification Number

NCT03514836

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

insufficient accrual

Study Start Date

May 23, 2018 (Actual)

Primary Completion Date

January 25, 2021 (Actual)

Study Completion Date

January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOTIO a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Castration-resistant Prostate Cancer

Keywords

Castrate-resistant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Open label combination treatment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCVac and ONCOS-102

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

DCVac/PCa

Other Intervention Name(s)

ONCOS-102

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

immunomodulatory medication given around the ONCOS-102 dosing

Primary Outcome Measure Information:

Title

Progression Free Survival

Description

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.

Time Frame

96 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Defined as the time from Baseline visit to the date of death for any cause

Time Frame

96 months

Title

Safety

Description

Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033

Time Frame

96 months

Title

Time to Progression-PSA

Description

demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2

Time Frame

96 months

Title

Radiographic Progression- free survival

Description

composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause

Time Frame

96 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate Cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roman Korolkiewicz, MD, PhD

Organizational Affiliation

Sotio as

Official's Role

Study Director

Facility Information:

Facility Name

Fakultní nemocnice v Motole

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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