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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
University Hospital Brno
Brno, Czechia
Masaryk Memorial Cancer Institute
Brno, Czechia
Hospital Novy Jicin
Nový Jičín, Czechia
University Hospital in Ostrava
Ostrava, Czechia
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
Time frame: Assessed from enrollment up to 104 weeks
Overall survival
Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Time frame: Assessed from enrolment through study completion approximately 5 years
Biological progression-free interval
Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
Time frame: CA-125 assessed every 6 weeks up to 104 weeks
Objective Response rate
CR and PR measured by the modifed RECIST 1.1 criteria
Time frame: Response is assessed every 8 weeks up to 104 weeks
Immunologic Response
Detection of entire anti-tumor immune response int he serum
Time frame: 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
Time frame: Screening through 30 days after completion of treatment
CA-125 response
Defined by GCIG criteria
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University Hospital Plzen
Pilsen, Czechia
University Hospital Kralovsko Vinohrady
Prague, Czechia
General University Hospital in Prague
Prague, Czechia
Hospital Bulovka
Prague, Czechia
Time frame: 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
Time frame: From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks.