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 (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female aged ≥18 years
Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
Optimally debulked (zero residuum) or maximal residuum \<1cm
Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2
You may not be if
FIGO I,II,IV epithelial ovarian cancer
FIGO III clear cells epithelial ovarian cancer
Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
Post-surgery residual disease with lesion(s) \>1cm
Prior or current systemic anti-cancer therapy for ovarian cancer \[for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\]
Previous or concurrent 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
Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
Evidence of active bacterial, viral or fungal infection requiring systemic treatment
Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) \< 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present
Clareo Health | Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
