We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE June 16, 2018
First Posted Date  ICMJE June 28, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
Effect on tumor size [ Time Frame: Monthly for 3 months ]
Changes in tumor size and lymph node burden (if any) compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Immunotherapy Trial for Breast Cancer
Official Title  ICMJE Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Breast Cancer
Intervention  ICMJE Biological: V3-MOMMO
Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months
Study Arms  ICMJE 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
Intervention: Biological: V3-MOMMO
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Mastectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Majority of subjects with breast cancer are females
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03572361
Other Study ID Numbers  ICMJE V3-MOMMO-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Immunitor LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immunitor LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aldar Bourinbayar, PhD, MD/PhD Immunitor LLC
PRS Account Immunitor LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP