Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
NCT ID: NCT02107937
Last Updated: 2022-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2013-11-30
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCVAC/OvCa with Standard of Care
DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
DCVAC/OvCa with Standard of Care
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa sequentially after chemotherapy
DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
Standart of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Standard of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Interventions
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DCVAC/OvCa with Standard of Care
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
Standard of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
* Optimally debulked (zero residuum) or maximal residuum \<1cm
* Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2
Exclusion Criteria
* FIGO III clear cells epithelial ovarian cancer
* Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
* Post-surgery residual disease with lesion(s) \>1cm
* Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\]
* Previous or concurrent radiotherapy to the abdomen and pelvis
* 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
* Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
* Evidence of active bacterial, viral or fungal infection requiring systemic treatment
* Clinically significant cardiovascular disease including:
Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) \< 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present
18 Years
FEMALE
No
Sponsors
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SOTIO a.s.
INDUSTRY
Responsible Party
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Principal Investigators
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Harald Fricke, MD, PhD
Role: STUDY_DIRECTOR
SOTIO a.s.
Locations
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Brno, , Czechia
Brno, , Czechia
České Budějovice, , Czechia
Hradec Králové, , Czechia
Nový Jičín, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Bialystok, , Poland
Lublin, , Poland
Countries
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References
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Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.
Fucikova J, Hensler M, Kasikova L, Lanickova T, Pasulka J, Rakova J, Drozenova J, Fredriksen T, Hraska M, Hrnciarova T, Sochorova K, Rozkova D, Sojka L, Dundr P, Laco J, Brtnicky T, Praznovec I, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Cibula D, Bartunkova J, Galon J, Galluzzi L, Spisek R. An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors. Clin Cancer Res. 2022 Jul 15;28(14):3053-3065. doi: 10.1158/1078-0432.CCR-21-4413.
Rob L, Cibula D, Knapp P, Mallmann P, Klat J, Minar L, Bartos P, Chovanec J, Valha P, Pluta M, Novotny Z, Spacek J, Melichar B, Kieszko D, Fucikova J, Hrnciarova T, Korolkiewicz RP, Hraska M, Bartunkova J, Spisek R. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer. 2022 Jan;10(1):e003190. doi: 10.1136/jitc-2021-003190.
Other Identifiers
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2013-001322-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SOV01
Identifier Type: -
Identifier Source: org_study_id
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