Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002196-26 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.
Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care chemotherapy + DCVAC/Ov | Experimental | Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCVAC/OvCa | Biological | activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival by modifications to the RECIST 1.1 | 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 | Assessed from enrollment up to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion | Assessed from enrolment through study completion approximately 5 years |
| Biological progression-free interval |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harald Fricke, MD, PhD | SOTIO a.s. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno | Brno | 625 00 | Czechia | |||
| Masaryk Memorial Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Not provided
Not provided
Not provided
Not provided
| Standard of Care Chemotherapy | Drug | either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa |
|
|
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria |
| CA-125 assessed every 6 weeks up to 104 weeks |
| Objective Response rate | CR and PR measured by the modifed RECIST 1.1 criteria | Response is assessed every 8 weeks up to 104 weeks |
| Immunologic Response | Detection of entire anti-tumor immune response int he serum | Blood samples collected 5 times throughout the study from enrolment up to 104 weeks |
| Incidence of Treatment-emergent adverse events [safety and tolerability] | 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 | Screening through 30 days after completion of treatment |
| CA-125 response | Defined by GCIG criteria | CA-125 assessed every 6 weeks up to 104 weeks |
| Time to either tumor or biologic Response | Response according to RECIST or CA-125 measurements as increased to >2 times ULN | From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks. |
| Brno |
| 656 53 |
| Czechia |
| Hospital Novy Jicin | Nový Jičín | 741 01 | Czechia |
| University Hospital in Ostrava | Ostrava | 708 52 | Czechia |
| University Hospital Plzen | Pilsen | 304 60 | Czechia |
| University Hospital Kralovsko Vinohrady | Prague | 100 34 | Czechia |
| General University Hospital in Prague | Prague | 128 08 | Czechia |
| Hospital Bulovka | Prague | 180 81 | Czechia |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| 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 |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided