Ovarian CancerPhase 2V3-OVANCT03556566
Open Label Immunotherapy Trial for Ovarian Cancer
A Phase 2 study testing Tableted vaccine (V3-OVA) containing ovarian cancer antigens in people with Ovarian Cancer, run by Immunitor LLC at 1 site in Mongolia.
Trial summary
This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Tableted vaccine (V3-OVA) containing ovarian cancer antigens
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMongolia
- Study dates
- 1 Jul 2018to 31 Dec 2019
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -
Who cannot join
- Metastases to other sites
- -
Trial locations and contacts
1 site in 1 country.
Mongolia1 site, 1 recruiting
- Recruiting
Immunitor LLC
Ulaanbaatar
Aldar Bourinbaiar, MD, 97695130306, aldar@immunitor.com
Marina Tarakanovskaya, MD, marinatarakanovskaya@yahoo.com
About this study
Official title: Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer
This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Read the detailed description
Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
- Conditions
- Ovarian Cancer
- Being tested
- Tableted vaccine (V3-OVA) containing ovarian cancer antigens
- Keywords
- ovary, ovarian, immunotherapy, cancer
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tableted vaccine (V3-OVA) containing ovarian cancer antigensBiological
Also called V3-OVA
One pill of V3-OVA per day for three months
| Study group | Role | What they receive |
|---|---|---|
| V3-OVA treatment arm | Experimental | Oral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer Receives: Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tumor size and burden compared to baseline
Intravaginal ultrasonography to measure changes in tumor size and burden
Measured: Monthly for 3 months
Secondary outcomes (1)
Effect on level of serum tumor markers compared to baseline
Commonly measured tumor markers associated with ovarian cancer, primarily CA125, at baseline and at study termination
Measured: Monthly for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jul 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunitor LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aldar Bourinbaiar, PhD, MD/PhD, Study chair, Immunitor LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556566
- Sponsor's protocol ID
- V3-OVA-01
- Acronym
- V3-OVA
- Status last verified
- Aug 2019
- First submitted
- 26 May 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon study completion in peer-reviewed publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-OVA as Immunotherapy of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03556566
- Acronym / sponsor ID
- V3-OVA / V3-OVA-01
- Conditions
- Ovarian Cancer
- Keywords
- ovary, ovarian, immunotherapy, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Immunitor LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jun 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 Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Detailed description
Ovarian cancer (OC) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. For treatment of OC, surgical intervention, chemotherapy, as well as radiation methods are used. Despite treatment, about 70% of patients have a relapse. Many different types of immunotherapy (especially checkpoint inhibitors) of OC being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. This Phase II will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. We will test new tableted preparation, V3-OVA, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label Phase II study in volunteers with ovarian cancer receiving daily dose of one pill of vaccine V3-OVA
| Arm | Type | Receives |
|---|---|---|
| V3-OVA treatment arm | Experimental | Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigensOral once daily pill of tableted vaccine (V3-OVA) containing ovarian cancer antigens administered for 3 months in 20 volunteers with ovarian cancer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -
Key exclusion criteria (2 listed)
- Metastases to other sites
- -
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 |
|---|---|---|
| Tableted vaccine (V3-OVA) containing ovarian cancer antigensAlso: V3-OVAOne pill of V3-OVA per day for three months | Biological | V3-OVA treatment arm |
Primary outcome
Changes in tumor size and burden compared to baseline
Time frame: Monthly for 3 months
Intravaginal ultrasonography to measure changes in tumor size and burden
1 secondary outcome
Effect on level of serum tumor markers compared to baseline
Time frame: Monthly for three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- review article on oral vaccinesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be shared upon study completion in peer-reviewed publication
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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.
Aldar Bourinbaiar, PhD, MD/PhD study chair
Immunitor LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tableted vaccine (V3-OVA) containing ovarian cancer antigens in people with Ovarian Cancer, run by Immunitor LLC at 1 site in Mongolia.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2019. 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 Mongolia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galyna Kutsyna, MD, MD/PhD (+97695130306, kutsynagalyna@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumor size and burden compared to baseline (time frame: Monthly for 3 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 30 Aug 2019.