Open Label Immunotherapy Trial for Breast Cancer (V3-MOMMO)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Mongolia
Study Type
Interventional
Intervention
V3-MOMMO
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level
Exclusion Criteria:
- Mastectomy
Sites / Locations
- Immunitor LLCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
V3-MOMMO
Arm Description
Oral once daily pill of tableted vaccine (V3-MOMMO) containing pooled breast cancer antigens administered for 3 months in 20 volunteers with breast cancer
Outcomes
Primary Outcome Measures
Effect on tumor size
Changes in tumor size and lymph node burden (if any) compared to baseline
Secondary Outcome Measures
Effect on level of serum tumor markers compared to baseline
Commonly measured tumor markers associated with breast cancer, primarily CA 15-3, CA 27.29, and CEA, at baseline and at study termination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03572361
Brief Title
Open Label Immunotherapy Trial for Breast Cancer
Acronym
V3-MOMMO
Official Title
Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V3-MOMMO
Arm Type
Experimental
Arm Description
Oral once daily pill of tableted vaccine (V3-MOMMO) containing pooled breast cancer antigens administered for 3 months in 20 volunteers with breast cancer
Intervention Type
Biological
Intervention Name(s)
V3-MOMMO
Intervention Description
Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months
Primary Outcome Measure Information:
Title
Effect on tumor size
Description
Changes in tumor size and lymph node burden (if any) compared to baseline
Time Frame
Monthly for 3 months
Secondary Outcome Measure Information:
Title
Effect on level of serum tumor markers compared to baseline
Description
Commonly measured tumor markers associated with breast cancer, primarily CA 15-3, CA 27.29, and CEA, at baseline and at study termination
Time Frame
Monthly for three months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Majority of subjects with breast cancer are females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level
Exclusion Criteria:
Mastectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galyna Kutsyna, MD, MD/PhD
Phone
+97695130306
Email
kutsynagalyna@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aldar Bourinbayar, MD
Phone
+97695130306
Email
marinatarakanovskaya@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbayar, PhD, MD/PhD
Organizational Affiliation
Immunitor LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Immunitor LLC
City
Ulaanbaatar
Country
Mongolia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbaiar, MD
Phone
97695130306
Email
aldar@immunitor.com
First Name & Middle Initial & Last Name & Degree
Marina Tarakanovskaya, MD
Email
marinatarakanovskaya@yahoo.com
First Name & Middle Initial & Last Name & Degree
Galyna Kutsyna, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28443252
Citation
Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.
Results Reference
background
Learn more about this trial
Open Label Immunotherapy Trial for Breast Cancer
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