DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 2021-02-25
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOTIO a.s.
• Treatments: Albumin-Bound Paclitaxel; Antineoplastic Agents; Carboplatin; Gemcitabine; Paclitaxel

Criteria

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