DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithe⦠(NCT03657966) | Clinical Trial Compass
CompletedPhase 2
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer
Czechia33 participantsStarted 2017-11-23
Plain-language 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)
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Progression Free Survival by modifications to the RECIST 1.1
Timeframe: Assessed from enrollment up to 104 weeks