DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
- Conditions
- Ovarian Cancer Recurrent
- Interventions
- Biological: DCVAC/OvCaDrug: Standard of Care Chemotherapy
- Registration Number
- NCT03657966
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 33
- 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
- Radiologically confirmed relapse after >6 months of remission ( platinum-sensitive cancer)
- Laboratory parameters per protocol
- FIGO I, II epithelial ovarian cancer
- FIGO III, IV clear cells epithelial ovarian cancer
- Non-epithelial ovarian cancer
- Borderline tumors ( tumors of low malignant potential)
- 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)
- fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
- Pregnant of lactating women
- Pre-defined co-morbidities
- Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard of care chemotherapy + DCVAC/Ov DCVAC/OvCa Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa Standard of care chemotherapy + DCVAC/Ov Standard of Care Chemotherapy Standard-of-care carboplatin/gemcitabine or carboplatin/paclitaxel followed by DCVAC/OvCa
- Primary Outcome Measures
Name Time Method Progression Free Survival by modifications to the RECIST 1.1 Assessed from enrollment up to 104 weeks 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
- Secondary Outcome Measures
Name Time Method Overall survival Assessed from enrolment through study completion approximately 5 years Defined as the time from first dose of SoC therapy administered until death due to any cause assessed until study completion
Immunologic Response Blood samples collected 5 times throughout the study from enrolment up to 104 weeks Detection of entire anti-tumor immune response int he serum
Biological progression-free interval CA-125 assessed every 6 weeks up to 104 weeks Defined by increasing CA-125 levels per Gynecologic Cancer Intergroup (GCIG) criteria
Time to either tumor or biologic Response From first dose of chemotherapy until either objective or serologic progression for up to 104 weeks. Response according to RECIST or CA-125 measurements as increased to \>2 times ULN
Objective Response rate Response is assessed every 8 weeks up to 104 weeks CR and PR measured by the modifed RECIST 1.1 criteria
CA-125 response CA-125 assessed every 6 weeks up to 104 weeks Defined by GCIG criteria
Incidence of Treatment-emergent adverse events [safety and tolerability] Screening through 30 days after completion of treatment 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
Trial Locations
- Locations (8)
General University Hospital in Prague
🇨🇿Prague, Czechia
Hospital Bulovka
🇨🇿Prague, Czechia
University Hospital Kralovsko Vinohrady
🇨🇿Prague, Czechia
University Hospital Brno
🇨🇿Brno, Czechia
Hospital Novy Jicin
🇨🇿Nový Jičín, Czechia
Masaryk Memorial Cancer Institute
🇨🇿Brno, Czechia
University Hospital in Ostrava
🇨🇿Ostrava, Czechia
University Hospital Plzen
🇨🇿Plzen, Czechia