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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001322-26 | EudraCT Number |
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The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC/OvCa with Standard of Care | Experimental | DCVAC/OvCa in parallel with chemotherapy (Standard of Care) |
|
| DCVAC/OvCa sequentially chemotherapy | Experimental | DCVAC/OvCa sequentially after chemotherapy |
|
| Standart of Care | Active Comparator | Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCVAC/OvCa with Standard of Care | Biological | DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall progression free survival (PFS) | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in remission after first line chemotherapy at 6 months | 0,10, 18, 30, 42 weeks | |
| Proportion of patients in remission after first line chemotherapy at 12 months | 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Harald Fricke, MD, PhD | SOTIO a.s. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | 625 00 | Czechia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35898703 | Derived | 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. | |
| 35536547 |
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EMA website
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| DCVAC/OvCa sequentially chemotherapy | Biological | DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel |
|
|
| Standard of Care | Drug | Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy |
|
|
| Biological progression free interval | 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks |
| Immunological Response | 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks |
| Proportion of patients requiring 2nd line chemotherapy | 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks |
| Frequency of Adverse Events | 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks |
| Time to 50 percent survival | 0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks |
| Brno |
| 656 53 |
| Czechia |
| České Budějovice | 370 01 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Nový Jičín | 741 01 | Czechia |
| Olomouc | 775 20 | Czechia |
| Ostrava | 708 52 | Czechia |
| Pilsen | 304 60 | Czechia |
| Prague | 100 34 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 150 06 | Czechia |
| Bialystok | 15-276 | Poland |
| Lublin | 20-090 | Poland |
| Derived |
| 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. |
| 34992091 | Derived | 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. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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