Clinical trial NCT03572361: Open Label Immunotherapy Trial for Breast Cancer
Official title: Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
First posted: 2018-06-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Mastectomy

Primary outcomes:
measure: Effect on tumor size
timeFrame: Monthly for 3 months
Secondary outcomes:
measure: Effect on level of serum tumor markers compared to baseline
timeFrame: Monthly for three months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
affiliation: Immunitor LLC
name: Aldar Bourinbayar, PhD, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.