Castration-resistant Prostate CancerPhase 1/2NCT03514836
A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
A Phase 1/2 study testing DCVac/PCa and Cyclophosphamide in people with Castration-resistant Prostate Cancer, run by SOTIO a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- DCVac/PCa and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCzechia
- Study dates
- 23 May 2018to 25 Jan 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- DCVac/PCa, Cyclophosphamide
- Keywords
- Castrate-resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVac/PCaBiological
Also called ONCOS-102
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.
CyclophosphamideDrug
immunomodulatory medication given around the ONCOS-102 dosing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: DCVac/PCa; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 months
Secondary outcomes (4)
Overall Survival
Defined as the time from Baseline visit to the date of death for any cause
Measured: 96 months
Safety
Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033
Measured: 96 months
Time to Progression-PSA
demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2
Measured: 96 months
Radiographic Progression- free survival
composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause
Measured: 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start23 May 2018
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Why it stopped: insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label combination treatment
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Korolkiewicz, MD, PhD, Study director, Sotio as
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514836
- Sponsor's protocol ID
- SP015
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03514836
- Acronym / sponsor ID
- SP015
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Castrate-resistant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label combination treatment
| Arm | Type | Receives |
|---|---|---|
| DCVac and ONCOS-102 | Experimental | Biological: DCVac/PCa, Drug: CyclophosphamideONCOS-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCVac/PCaAlso: ONCOS-102Oncolytic 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. | Biological | DCVac and ONCOS-102 |
| Cyclophosphamideimmunomodulatory medication given around the ONCOS-102 dosing | Drug | DCVac and ONCOS-102 |
Primary outcome
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.
4 secondary outcomes
Overall Survival
Time frame: 96 months
Safety
Time frame: 96 months
Time to Progression-PSA
Time frame: 96 months
Radiographic Progression- free survival
Time frame: 96 months
Results and safety
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Castration-resistant Prostate Cancer
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Korolkiewicz, MD, PhD study director
Sotio as
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DCVac/PCa and Cyclophosphamide in people with Castration-resistant Prostate Cancer, run by SOTIO a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 96 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.