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

SOTIO

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer Recurrent

Treatments

Biological: DCVAC/OvCa

Drug: Standard of Care Chemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03657966

2017-002196-26 (EudraCT Number)

SOV06

Details and patient eligibility

About

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)

Full 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.

Enrollment

33 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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