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Open Label Immunotherapy Trial for Breast Cancer (V3-MOMMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572361
Recruitment Status : Unknown
Verified August 2019 by Immunitor LLC.
Recruitment status was:  Recruiting
First Posted : June 28, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Immunitor LLC

Study Description
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Brief Summary:
This Phase II will evaluate a new type of breast cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. Investigators will test new tableted preparation, V3-MOMMO, obtained from hydrolyzed, inactivated blood and tumors of patients with breast cancer. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: V3-MOMMO Phase 2

Detailed Description:

Worldwide, breast cancer is the number one cancer in women. It affects about 12% or 1.7 mln women worldwide. In Mongolia breast cancer is less common, occupies 5-th place by frequency in women, the incidence is 118 per 100,000 or 1,770 cases per year.

Many different types of immunotherapy (especially checkpoint inhibitors) are 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 breast cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. Investigators will test new tableted preparation, V3-MOMMO, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with breast cancer. 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 lymph nodes burden after 3 months. Secondary endpoint will be effect on levels of tumor markers (i.e., cancer antigen 15-3 (CA 15-3), cancer antigen 27.29 (CA 27.29), and carcinoembryonic antigen (CEA) on monthly basis compared to baseline.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open label Phase II study in volunteers with breast cancer receiving daily dose of one pill of vaccine V3-MOMMO
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: V3-MOMMO
Oral once daily pill of tableted vaccine (V3-MOMMO) containing pooled breast cancer antigens administered for 3 months in 20 volunteers with breast cancer
 Biological: V3-MOMMO
Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Effect on tumor size [ Time Frame: Monthly for 3 months ]
    Changes in tumor size and lymph node burden (if any) compared to baseline


Secondary Outcome Measures :
  1. Effect on level of serum tumor markers compared to baseline [ Time Frame: Monthly for three months ]
    Commonly measured tumor markers associated with breast cancer, primarily CA 15-3, CA 27.29, and CEA, at baseline and at study termination


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Majority of subjects with breast cancer are females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level

Exclusion Criteria:

  • Mastectomy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572361


Contacts
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Contact: Galyna Kutsyna, MD, MD/PhD +97695130306 kutsynagalyna@yahoo.com
Contact: Aldar Bourinbayar, MD +97695130306 marinatarakanovskaya@yahoo.com

Locations
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Mongolia
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306    aldar@immunitor.com   
Contact: Marina Tarakanovskaya, MD       marinatarakanovskaya@yahoo.com   
Principal Investigator: Galyna Kutsyna, MD         
Sponsors and Collaborators
Immunitor LLC
Investigators
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Principal Investigator: Aldar Bourinbayar, PhD, MD/PhD Immunitor LLC
More Information
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Publications:

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Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT03572361    
Other Study ID Numbers: V3-MOMMO-01
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases