Ovarian Cancer RecurrentPhase 2NCT03657966
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
A Phase 2 study testing DCVAC/OvCa in people with Ovarian Cancer Recurrent, run by SOTIO a.s. at 8 sites in Czechia.
Trial summary
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- DCVAC/OvCa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesCzechia
- Study dates
- 23 Nov 2017to 25 Feb 2021
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
- Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
- Laboratory parameters per protocol
Who cannot join
- FIGO I, II epithelial ovarian cancer
- FIGO III, IV clear cells epithelial ovarian cancer
- Non-epithelial ovarian cancer
- Borderline tumors ( tumors of low malignant potential)
- Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
- fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
Show all 9Show fewer
- Pregnant of lactating women
- Pre-defined co-morbidities
- Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Czechia8 sites
University Hospital Brno
Brno, 625 00
Masaryk Memorial Cancer Institute
Brno, 656 53
Hospital Novy Jicin
Nový Jičín, 741 01
University Hospital in Ostrava
Ostrava, 708 52
University Hospital Plzen
Pilsen, 304 60
University Hospital Kralovsko Vinohrady
Prague, 100 34
General University Hospital in Prague
Prague, 128 08
Hospital Bulovka
Prague, 180 81
About this study
Official title: An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)
Read the detailed description
All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.
After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.
Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- DCVAC/OvCa, Standard of Care Chemotherapy
- Keywords
- Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells, chemotherapy, leukapheresis, FIGO III, FIGO IV
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVAC/OvCaBiological
activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
Standard of Care ChemotherapyDrug
Also called carboplatin with gemcitabine, carboplatin with paclitaxel
either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
| Study group | Role | What they receive |
|---|---|---|
| Standard of care chemotherapy + DCVAC/Ov | Experimental | Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa Receives: Biological: DCVAC/OvCa; Drug: Standard of Care Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival by modifications to the RECIST 1.1
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
Measured: Assessed from enrollment up to 104 weeks
Secondary outcomes (7)
Overall survival
Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Measured: Assessed from enrolment through study completion approximately 5 years
Biological progression-free interval
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
Measured: CA-125 assessed every 6 weeks up to 104 weeks
Objective Response rate
CR and PR measured by the modifed RECIST 1.1 criteria
Measured: Response is assessed every 8 weeks up to 104 weeks
Immunologic Response
Detection of entire anti-tumor immune response int he serum
Measured: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Incidence of Treatment-emergent adverse events [safety and tolerability]
Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0
Measured: Screening through 30 days after completion of treatment
CA-125 response
Defined by GCIG criteria
Measured: CA-125 assessed every 6 weeks up to 104 weeks
Time to either tumor or biologic Response
Response according to RECIST or CA-125 measurements as increased to >2 times ULN
Measured: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start23 Nov 2017
- Primary completion11 Nov 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harald Fricke, MD, PhD, Study director, SOTIO a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657966
- Sponsor's protocol ID
- SOV06
- Other IDs
- 2017-002196-26, 2017
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2018
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03657966
- Acronym / sponsor ID
- SOV06
- Conditions
- Ovarian Cancer Recurrent
- Keywords
- Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 5 Sep 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.
The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)
Detailed description
All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.
After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.
Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
| Arm | Type | Receives |
|---|---|---|
| Standard of care chemotherapy + DCVAC/Ov | Experimental | Biological: DCVAC/OvCa, Drug: Standard of Care ChemotherapyStandard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
- Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
- Laboratory parameters per protocol
Key exclusion criteria (9 listed)
- FIGO I, II epithelial ovarian cancer
- FIGO III, IV clear cells epithelial ovarian cancer
- Non-epithelial ovarian cancer
- Borderline tumors ( tumors of low malignant potential)
- Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
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/OvCaactivated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy | Biological | Standard of care chemotherapy + DCVAC/Ov |
| Standard of Care ChemotherapyAlso: carboplatin with gemcitabine, carboplatin with paclitaxeleither carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa | Drug | Standard of care chemotherapy + DCVAC/Ov |
Primary outcome
Progression Free Survival by modifications to the RECIST 1.1
Time frame: Assessed from enrollment up to 104 weeks
PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause
7 secondary outcomes
Overall survival
Time frame: Assessed from enrolment through study completion approximately 5 years
Biological progression-free interval
Time frame: CA-125 assessed every 6 weeks up to 104 weeks
Objective Response rate
Time frame: Response is assessed every 8 weeks up to 104 weeks
Immunologic Response
Time frame: Blood samples collected 5 times throughout the study from enrolment up to 104 weeks
Incidence of Treatment-emergent adverse events [safety and tolerability]
Time frame: Screening through 30 days after completion of treatment
CA-125 response
Time frame: CA-125 assessed every 6 weeks up to 104 weeks
Time to either tumor or biologic Response
Time frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Harald Fricke, MD, PhD study director
SOTIO a.s.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCVAC/OvCa in people with Ovarian Cancer Recurrent, run by SOTIO a.s. at 8 sites 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 by modifications to the RECIST 1.1 (time frame: Assessed from enrollment up to 104 weeks). 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 21 Apr 2021.