Ovarian NeoplasmsPhase 2NCT02107950
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
A Phase 2 study testing DCVAC/OvCa in parallel with chemotherapy in people with Ovarian Neoplasms and Ovarian Cancer (OvCa), run by SOTIO a.s. at 16 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovarian Cancer (OvCa), Ovarian Epithelial Cancer
- What is being tested?
- DCVAC/OvCa in parallel with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Nov 2013to 17 May 2017
- 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
- Females 18 years old and older
- Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (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 (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
- Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
- The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study
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 [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab)
- Previous radiotherapy to the abdomen and pelvis
- Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Czechia9 sites
Study site
Brno, 625 00
Study site
Brno, 656 53
Study site
České Budějovice, 370 01
Study site
Hradec Králové, 500 05
Study site
Nový Jičín, 741 01
Study site
Olomouc, 755 20
Study site
Ostrava, 708 52
Study site
Prague, 128 08
Study site
Prague, 150 06
Poland4 sites
Study site
Bialystok, 15-276
Study site
Krakow, 31-501
Study site
Lublin, 20-081
Study site
Poznan, 60-569
Germany3 sites
Study site
Cologne, 50931
Study site
Dresden, 01307
Study site
Erlangen, 91 054
About this study
Official title: A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Read the detailed description
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
- Being tested
- DCVAC/OvCa in parallel with chemotherapy, Standard of Care
- Keywords
- Ovarian, Platinum Sensitive, Epithelial
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCVAC/OvCa in parallel with chemotherapyBiological
Also called DCVAC/OvCa, carboplatin and gemcitabine
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
Standard of CareDrug
Also called Carboplatin and Gemcitabine
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/OvCa in parallel with chemotherapy | Experimental | Combination therapy with DCVAC/OvCa and Standard of Care Receives: Biological: DCVAC/OvCa in parallel with chemotherapy |
| Standard of Care | Active comparator | Standard of Care carboplatin and gemcitabine Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine median progression free survival
Measured: 72 Week
Secondary outcomes (5)
Overall survival (all causes)
Measured: 56, 64, 72 weeks
Objective Response Rate
Measured: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Biological Progression Free Interval
Measured: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
Immunological Response
Measured: 24, 48, 72 weeks
Frequency of adverse events
Measured: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2016
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ales Horacek, Study director, Accord Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107950
- Sponsor's protocol ID
- SOV02
- Other IDs
- 2013-001323-38
- Status last verified
- Jan 2016
- First submitted
- 4 Apr 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: will be posted to EMA website
Publications
Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.
PubMed 34294416
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT02107950
- Acronym / sponsor ID
- SOV02
- Keywords
- Ovarian, Platinum Sensitive, Epithelial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 8 Apr 2014 (estimated)
- 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 study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Detailed description
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCVAC/OvCa in parallel with chemotherapy | Experimental | Biological: DCVAC/OvCa in parallel with chemotherapyCombination therapy with DCVAC/OvCa and Standard of Care |
| Standard of Care | Active comparator | Drug: Standard of CareStandard of Care carboplatin and gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females 18 years old and older
- Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (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 (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
- Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
- The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study
Key exclusion criteria (7 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 [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-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/OvCa in parallel with chemotherapyAlso: DCVAC/OvCa, carboplatin and gemcitabineDCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine | Biological | DCVAC/OvCa in parallel with chemotherapy |
| Standard of CareAlso: Carboplatin and GemcitabineCarboplatin and Gemcitabine is Standard of Care First Line Chemotherapy | Drug | Standard of Care |
Primary outcome
Determine median progression free survival
Time frame: 72 Week
5 secondary outcomes
Overall survival (all causes)
Time frame: 56, 64, 72 weeks
Objective Response Rate
Time frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Biological Progression Free Interval
Time frame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
Immunological Response
Time frame: 24, 48, 72 weeks
Frequency of adverse events
Time frame: 8, 16, 24, 32, 40, 48, 56. 64. 72 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 15 Aug 2018.
- Derived from this study: PubMed 34294416Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.
- Individual participant dataSharing planned: Yes. will be posted to EMA website
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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.
Ales Horacek study director
Accord Research
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCVAC/OvCa in parallel with chemotherapy in people with Ovarian Neoplasms and Ovarian Cancer (OvCa), run by SOTIO a.s. at 16 sites in 3 countries.
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 4 inclusion and 7 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Poland, Germany. 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?
Determine median progression free survival (time frame: 72 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02107950, which also lists 1 linked publication.
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 15 Aug 2018.