Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-04 @ 9:00 AM
Study NCT ID:
NCT03572361
Status:
UNKNOWN
Last Update Posted:
2019-08-30
First Post:
2018-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Immunotherapy Trial for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, open label Phase II study in volunteers with breast cancer receiving daily dose of one pill of vaccine V3-MOMMO'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2018-06-16', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on tumor size', 'timeFrame': 'Monthly for 3 months', 'description': 'Changes in tumor size and lymph node burden (if any) compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Effect on level of serum tumor markers compared to baseline', 'timeFrame': 'Monthly for three months', 'description': 'Commonly measured tumor markers associated with breast cancer, primarily CA 15-3, CA 27.29, and CEA, at baseline and at study termination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28443252', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMany 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Majority of subjects with breast cancer are females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level\n\nExclusion Criteria:\n\n* Mastectomy'}, 'identificationModule': {'nctId': 'NCT03572361', 'acronym': 'V3-MOMMO', 'briefTitle': 'Open Label Immunotherapy Trial for Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunitor LLC'}, 'officialTitle': 'Open Label, One-arm, 3-month Study of Once-daily Tablet of V3-MOMMO as Immunotherapy of Breast Cancer', 'orgStudyIdInfo': {'id': 'V3-MOMMO-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V3-MOMMO', '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', 'interventionNames': ['Biological: V3-MOMMO']}], 'interventions': [{'name': 'V3-MOMMO', 'type': 'BIOLOGICAL', 'description': 'Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months', 'armGroupLabels': ['V3-MOMMO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'status': 'RECRUITING', 'country': 'Mongolia', 'contacts': [{'name': 'Aldar Bourinbaiar, MD', 'role': 'CONTACT', 'email': 'aldar@immunitor.com', 'phone': '97695130306'}, {'name': 'Marina Tarakanovskaya, MD', 'role': 'CONTACT', 'email': 'marinatarakanovskaya@yahoo.com'}, {'name': 'Galyna Kutsyna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Immunitor LLC', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'centralContacts': [{'name': 'Galyna Kutsyna, MD, MD/PhD', 'role': 'CONTACT', 'email': 'kutsynagalyna@yahoo.com', 'phone': '+97695130306'}, {'name': 'Aldar Bourinbayar, MD', 'role': 'CONTACT', 'email': 'marinatarakanovskaya@yahoo.com', 'phone': '+97695130306'}], 'overallOfficials': [{'name': 'Aldar Bourinbayar, PhD, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunitor LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunitor LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}