Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-02 @ 7:13 AM
Study NCT ID:
NCT03657966
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2018-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], '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': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'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': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2018-08-24', 'studyFirstSubmitQcDate': '2018-08-30', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival by modifications to the RECIST 1.1', 'timeFrame': 'Assessed from enrollment up to 104 weeks', 'description': 'PFS as defined as the time from the first dose of Standard-of-Care (SoC) therapy administerd until tumor progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Assessed from enrolment through study completion approximately 5 years', 'description': 'Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion'}, {'measure': 'Biological progression-free interval', 'timeFrame': 'CA-125 assessed every 6 weeks up to 104 weeks', 'description': 'Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria'}, {'measure': 'Objective Response rate', 'timeFrame': 'Response is assessed every 8 weeks up to 104 weeks', 'description': 'CR and PR measured by the modifed RECIST 1.1 criteria'}, {'measure': 'Immunologic Response', 'timeFrame': 'Blood samples collected 5 times throughout the study from enrolment up to 104 weeks', 'description': 'Detection of entire anti-tumor immune response int he serum'}, {'measure': 'Incidence of Treatment-emergent adverse events [safety and tolerability]', 'timeFrame': 'Screening through 30 days after completion of treatment', 'description': 'Safety profile as determined by the nature, incidence, duration, severity and outcome of adverse events (AEs) including serious AEs (SAEs) as assessed by CTCAE v. 4.0'}, {'measure': 'CA-125 response', 'timeFrame': 'CA-125 assessed every 6 weeks up to 104 weeks', 'description': 'Defined by GCIG criteria'}, {'measure': 'Time to either tumor or biologic Response', 'timeFrame': 'From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.', 'description': 'Response according to RECIST or CA-125 measurements as increased to \\>2 times ULN'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Platinum-sensitive', 'Biologic', 'Vaccine', 'Ovarian cancer', 'Fallopian Tube cancer', 'Primary peritoneal cancer', 'dendritic cells', 'chemotherapy', 'leukapheresis', 'FIGO III', 'FIGO IV'], 'conditions': ['Ovarian Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)', 'detailedDescription': 'All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.\n\nAfter 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.\n\nTreatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed 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-based chemotherapy\n* Radiologically confirmed relapse after \\>6 months of remission ( platinum-sensitive cancer)\n* Laboratory parameters per protocol\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 (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)\n* fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods\n* Pregnant of lactating women\n* Pre-defined co-morbidities\n* Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds'}, 'identificationModule': {'nctId': 'NCT03657966', 'briefTitle': 'DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sotio Biotech Inc.'}, 'officialTitle': 'An Open-label, Single-group, Multi-center, Phase II Clinical Trial Evaluating the Effect of Maintenance DCVAC/OvCa After Standard-of-care Therapy in Women With First Relapse of Platinum-sensitive Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'SOV06'}, 'secondaryIdInfos': [{'id': '2017-002196-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard of care chemotherapy + DCVAC/Ov', 'description': 'Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa', 'interventionNames': ['Biological: DCVAC/OvCa', 'Drug: Standard of Care Chemotherapy']}], 'interventions': [{'name': 'DCVAC/OvCa', 'type': 'BIOLOGICAL', 'description': 'activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy', 'armGroupLabels': ['Standard of care chemotherapy + DCVAC/Ov']}, {'name': 'Standard of Care Chemotherapy', 'type': 'DRUG', 'otherNames': ['carboplatin with gemcitabine', 'carboplatin with paclitaxel'], 'description': 'either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa', 'armGroupLabels': ['Standard of care chemotherapy + DCVAC/Ov']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '656 53', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Masaryk Memorial Cancer Institute', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '741 01', 'city': 'Nový Jičín', 'country': 'Czechia', 'facility': 'Hospital Novy Jicin', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '708 52', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'University Hospital in Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '304 60', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'University Hospital Plzen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Kralovsko Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180 81', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Hospital Bulovka', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Harald Fricke, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SOTIO a.s.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOTIO a.s.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}