A Phase 2 interventional study of V3-MOMMO in Breast Cancer, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Immunitor LLC · Phase 2, Interventional, and Treatment
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Effect on tumor size
Changes in tumor size and lymph node burden (if any) compared to baseline
Time frame: Monthly for 3 months
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
Time frame: Monthly for three months
Plan to share: No
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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