Overview

Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma

Status:
Completed
Trial end date:
2017-05-17
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SOTIO a.s.
Treatments:
Carboplatin
Gemcitabine
Criteria
Inclusion Criteria:

- Females 18 years old and older

- Patients with histologically confirmed, International Federation of Gynecology and
Obstetrics (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 (Pt)-based chemotherapy and are selected to receive second line
Standard of Care chemotherapy

- Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive
patients), found up to 4 weeks prior study entry.

- The patient must have at least one measureable target lesion as defined by the
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for
enrolment in the study

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 [for example
chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy,
vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first
line Platinum-based chemotherapy (with or without bevacizumab)

- Previous radiotherapy to the abdomen and pelvis

- Malignancy other than epithelial ovarian cancer, except those that have been in
clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the
cervix or non-melanoma skin carcinomas