Ovarian Cancer Recurrent
Conditions
Keywords
Immunotherapy, Platinum-sensitive, Biologic, Vaccine, Ovarian cancer, Fallopian Tube cancer, Primary peritoneal cancer, dendritic cells, chemotherapy, leukapheresis, FIGO III, FIGO IV
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.
Interventions
BIOLOGICALDCVAC/OvCa
activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
Sponsors
SOTIO a.s.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label DCVAC/OvCa after treatment with carboplatin in combination with either gemcitabine or paclitaxel
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Objective Response rate | Response is assessed every 8 weeks up to 104 weeks | CR and PR measured by the modifed RECIST 1.1 criteria |
| 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 |
| 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 |
| CA-125 response | CA-125 assessed every 6 weeks up to 104 weeks | Defined by 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 |
| 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 |
Countries
Czechia
Outcome results
None listed