Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SOTIO a.s.
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy may result in prolongation of Overall Survival (OS).
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Females 18 years or older
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 have undergone initial surgery or interval debulking surgery but have not reached complete remission of more than 6 months after first line platinum based chemotherapy, for one of the following reasons
Patients are platinum-refractory (no response)
Complete remission was not reached (partial responders)
Relapse within ≤6 months of remission (Platinum-resistant)
Platinum-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Platinum-resistant) or by finding described as 'did not reach complete clinical remission' (Platinum-refractory or Platinum-partial response) Patients must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
You may not be if
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
Clinically significant cardiovascular disease
Active autoimmune disease requiring treatment
History of severe forms of primary immune deficiencies
