Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02107950
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine median progression free survival', 'timeFrame': '72 Week'}], 'secondaryOutcomes': [{'measure': 'Overall survival (all causes)', 'timeFrame': '56, 64, 72 weeks'}, {'measure': 'Objective Response Rate', 'timeFrame': '8, 16, 24, 32, 40, 48, 56. 64. 72 weeks'}, {'measure': 'Biological Progression Free Interval', 'timeFrame': '6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks'}, {'measure': 'Immunological Response', 'timeFrame': '24, 48, 72 weeks'}, {'measure': 'Frequency of adverse events', 'timeFrame': '8, 16, 24, 32, 40, 48, 56. 64. 72 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ovarian', 'Platinum Sensitive', 'Epithelial'], 'conditions': ['Ovarian Neoplasms', 'Ovarian Cancer (OvCa)', 'Ovarian Epithelial Cancer']}, 'referencesModule': {'references': [{'pmid': '34294416', 'type': 'DERIVED', 'citation': 'Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).', 'detailedDescription': 'The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females 18 years old and older\n* Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy\n* Radiologically confirmed relapse after \\>6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.\n* The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study\n\nExclusion Criteria:\n\n* FIGO I,II epithelial ovarian cancer\n* FIGO III, IV clear cells epithelial ovarian cancer\n* Non-epithelial ovarian cancer\n* Borderline tumors (tumors of low malignant potential)\n* Prior or current systemic anti-cancer therapy for ovarian cancer \\[for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\\] except first line Platinum-based chemotherapy (with or without bevacizumab)\n* Previous radiotherapy to the abdomen and pelvis\n* Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas'}, 'identificationModule': {'nctId': 'NCT02107950', 'briefTitle': 'Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sotio Biotech Inc.'}, 'officialTitle': 'A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma', 'orgStudyIdInfo': {'id': 'SOV02'}, 'secondaryIdInfos': [{'id': '2013-001323-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCVAC/OvCa in parallel with chemotherapy', 'description': 'Combination therapy with DCVAC/OvCa and Standard of Care', 'interventionNames': ['Biological: DCVAC/OvCa in parallel with chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of Care carboplatin and gemcitabine', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'DCVAC/OvCa in parallel with chemotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['DCVAC/OvCa', 'carboplatin and gemcitabine'], 'description': 'DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine', 'armGroupLabels': ['DCVAC/OvCa in parallel with chemotherapy']}, {'name': 'Standard of Care', 'type': 'DRUG', 'otherNames': ['Carboplatin and Gemcitabine'], 'description': 'Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '656 53', 'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '370 01', 'city': 'České Budějovice', 'country': 'Czechia', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '741 01', 'city': 'Nový Jičín', 'country': 'Czechia', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '755 20', 'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '91 054', 'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '15-276', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-569', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Ales Horacek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Accord Research'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'estimate end of 2018', 'ipdSharing': 'YES', 'description': 'will be posted to EMA website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOTIO a.s.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}