Overview

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