Ovarian CancerPhase 3VITALIANCT03905902
DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
A Phase 3 study testing DCVAC/OvCa in people with Ovarian Cancer and Fallopian Tube Cancer, run by SOTIO a.s..
Trial summary
Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- What is being tested?
- DCVAC/OvCa
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to 16 Aug 2021
- Phase
- Phase 3
- 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
- Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
- Without disease progression during preceding platinum-based chemotherapy
- Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression.
- First relapse identified by the criteria above up to 28 days prior to study randomization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Known BRCA (breast cancer susceptibility gene) mutation status before randomization
- Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi
Who cannot join
- Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed
- Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy
- Intention to treat with intra-peritoneal chemotherapy
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.
Read the detailed description
All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Being tested
- DCVAC/OvCa, DCVAC/OvCa placebo
- Keywords
- active cellular immunotherapy, dendritic cells, platinum-sensitive, relapsed ovarian cancer, biologic
- 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
Also called dendritic cell vaccine/ ovarian cancer
activated autologous dendritic cells
DCVAC/OvCa placeboBiological
placebo for activated autologous cells
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/OvCa with standard of care | Experimental | Induction period: DCVAC/OvCa with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and pegylated liposomal doxorubicin, with or without bevacizumab
Maintenance period: DCVAC/OvCa with bevacizumab, best supportive care or a PARPi Receives: Biological: DCVAC/OvCa; Biological: DCVAC/OvCa placebo |
| Placebo with standard of care | Placebo comparator | Induction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab
Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi Receives: Biological: DCVAC/OvCa; Biological: DCVAC/OvCa placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
Defined as the time from randomization until the date of death due to any cause.
Measured: Assessed from enrolment up to study completion, approximately 6.6 years
Secondary outcomes (6)
Progression-Free Survival (PFS)
Defined as the time from randomization to the earlier date of objective progression or death due to any cause in the absence of progression.
Measured: Assessed from enrollment to up to 4 years
Objective Response Rate
Assessment of Objective Response Rate per RECIST1.1 until objective progression as defined by the Investigator.
Measured: Assessed from start of treatment to up to 4 years
Time to Relapse
Assessment of Time to Relapse, per objective progression according to RECIST 1.1.
Measured: Assessed from start of treatment up to 4 years
Duration of Response
Assessment of Duration of Response until objective progression per RECIST 1.1.
Measured: Assessed from start of study treatment up to 4 years
Biological Progression-Free Survival
Defined as the time from randomization to the earlier date of assessment of biological progression evaluated by increasing CA 125 levels or death due to any cause in the absence of progression.
Measured: Assessed from randomization up to study completion up to 6.6 years.
Safety Assessments: NCI CTCAE version 5.0
Defined as the incidence, severity and outcome of treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) assessed by NCI CTCAE version 5.0.
Measured: Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study startAug 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completion16 Aug 2021
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Responsible party
- Sponsor
- Investigators
- Harald Fricke, MD PhD, Study director, SOTIO a.s.David Cibula, Prof. MD PhD, Principal investigator, The Central and Eastern European Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905902
- Sponsor's protocol ID
- SOV09
- Other IDs
- VITALIA/ ENGOT-ov53
- Acronym
- VITALIA
- Status last verified
- Dec 2021
- First submitted
- 2 Apr 2019
- Last updated
- 23 Dec 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of DCVAC/OvCa Added to Standard of Care in Patients With Relapsed Platinum-sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT03905902
- Acronym / sponsor ID
- VITALIA / SOV09
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- Keywords
- active cellular immunotherapy, dendritic cells, platinum-sensitive, relapsed ovarian cancer, biologic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 8 Apr 2019 (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.
Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.
Detailed description
All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-group, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| DCVAC/OvCa with standard of care | Experimental | Biological: DCVAC/OvCa, Biological: DCVAC/OvCa placeboInduction period: DCVAC/OvCa with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and pegylated liposomal doxorubicin, with or without bevacizumab Maintenance period: DCVAC/OvCa with bevacizumab, best supportive care or a PARPi |
| Placebo with standard of care | Placebo comparator | Biological: DCVAC/OvCa, Biological: DCVAC/OvCa placeboInduction period: DCVAC Placebo with carboplatin and gemcitabine, or carboplatin and paclitaxel, or carboplatin and doxorubicin, with or without bevacizumab Maintenance Period:DCVAC placebo with bevacizumab, best supportive care or a PARPi carboplatin and gemcitabine or carboplatin and paclitaxel with or without bevacizumab, best supportive care or a PARPi |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
- Without disease progression during preceding platinum-based chemotherapy
- Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression.
- First relapse identified by the criteria above up to 28 days prior to study randomization
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (3 listed)
- Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed
- Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy
- Intention to treat with intra-peritoneal chemotherapy
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/OvCaAlso: dendritic cell vaccine/ ovarian canceractivated autologous dendritic cells | Biological | DCVAC/OvCa with standard of care, Placebo with standard of care |
| DCVAC/OvCa placeboplacebo for activated autologous cells | Biological | DCVAC/OvCa with standard of care, Placebo with standard of care |
Primary outcome
Overall Survival(OS)
Time frame: Assessed from enrolment up to study completion, approximately 6.6 years
Defined as the time from randomization until the date of death due to any cause.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Assessed from enrollment to up to 4 years
Objective Response Rate
Time frame: Assessed from start of treatment to up to 4 years
Time to Relapse
Time frame: Assessed from start of treatment up to 4 years
Duration of Response
Time frame: Assessed from start of study treatment up to 4 years
Biological Progression-Free Survival
Time frame: Assessed from randomization up to study completion up to 6.6 years.
Safety Assessments: NCI CTCAE version 5.0
Time frame: Assessed from Screening through 30 days after the completion of Investigational Medicinal Product approximately 18 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 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.
David Cibula, Prof. MD PhD principal investigator
The Central and Eastern European Gynecologic Oncology Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCVAC/OvCa in people with Ovarian Cancer and Fallopian Tube Cancer, run by SOTIO a.s..
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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Overall Survival(OS) (time frame: Assessed from enrolment up to study completion, approximately 6.6 years). 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 23 Dec 2021.