Open Label Immunotherapy Trial for Breast Cancer (V3-MOMMO)
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| ClinicalTrials.gov Identifier: NCT03572361 |
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Recruitment Status :
Recruiting
First Posted : June 28, 2018
Last Update Posted : August 30, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Biological: V3-MOMMO | Phase 2 |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Biological: V3-MOMMO
Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months |
- Effect on tumor size [ Time Frame: Monthly for 3 months ]Changes in tumor size and lymph node burden (if any) compared to baseline
- 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
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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 |
Inclusion Criteria:
- Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level
Exclusion Criteria:
- Mastectomy
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
| Contact: Galyna Kutsyna, MD, MD/PhD | +97695130306 | kutsynagalyna@yahoo.com | |
| Contact: Aldar Bourinbayar, MD | +97695130306 | marinatarakanovskaya@yahoo.com |
| 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 | |
| Principal Investigator: | Aldar Bourinbayar, PhD, MD/PhD | Immunitor LLC |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |