Open Label Immunotherapy Trial for Ovarian Cancer | NCT03556566

Studies
Open Label Immunotherapy Trial for Ovarian Cancer

NCT03556566

Sponsor

Immunitor LLC

Status

Unknown status

Last Update Posted

Aug 30, 2019Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Ovarian Cancer

Interventions

Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Countries

Mongolia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Nov 30, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

May 26, 2018

First Submission Date that Met QC Criteria

Jun 13, 2018

First Posted Date

Jun 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2019

Last Update Posted Date

Aug 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Biological: Tableted vaccine (V3-OVA) containing ovarian cancer antigens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tableted vaccine (V3-OVA) containing ovarian cancer antigens	Biological	One pill of V3-OVA per day for three months	V3-OVA treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in tumor size and burden compared to baseline	Intravaginal ultrasonography to measure changes in tumor size and burden	Monthly for 3 months

Secondary Outcomes

Measure	Description	Time Frame
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	Monthly for three months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of ovarian cancer Positive for CA125 tumor marker at above normal threshold level -

Exclusion Criteria:

Metastases to other sites

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Ovarian cancer is female gynecological cancer

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Galyna Kutsyna, MD, MD/PhD	Contact	+97695130306		kutsynagalyna@yahoo.com
Marina Tarakanovskaya, MD	Contact	+97695130306		marinatarakanovskaya@yahoo.com

Overall Officials

Name	Affiliation	Role
Aldar Bourinbaiar, PhD, MD/PhD	Immunitor LLC	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Immunitor LLC	Recruiting	Ulaanbaatar			Mongolia

References Module

Citations

Not provided

ID	Term
D010051	Ovarian Neoplasms
D009369	Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases