epithelial ovarian carcinoma MedDRA version: 20.0 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
SOTIO a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female aged =18 years 2. Patients with newly diagnosed, histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) 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) 3. Optimally debulked (zero residuum) or maximal residuum 4,000/mm3 (4.0 x109/L) - Neutrophil count >1,500/mm3 (1.5 x109/L) - Hemoglobin (Hb) =10g/dL (100g/L) - Platelet count =100,000/mm3 (100 x109/L) - Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert´s syndrome are permitted) - Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. FIGO I,II,IV epithelial ovarian cancer 2. FIGO III clear cells epithelial ovarian cancer 3. Non-epithelial ovarian cancer, borderline tumors (tumors of low malignant potential) 4. Post-surgery residual disease with lesion(s) >1cm 5. 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) 6. Previous or concurrent radiotherapy to the abdomen and pelvis 7. Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, or incidental low-grade carcinoid which has been totally extirpated during primary debulking surgery without signs of distant metastasis, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas 8. 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 - Clinically significant cardiovascular disease including: o Symptomatic congestive heart failure o Unstable angina pectoris o Serious cardiac arrhythmia requiring medication o Uncontrolled hypertension o Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present - Pericardial effusion of any National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade - Peripheral neuropathy having a CTCAE =Grade 2 - Active autoimmune disease requiring treatment - History of severe forms of primary immune deficiencies - History of anaphylaxis or other serious reaction following vaccination - Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial 9. Known hypersensitivity to any constituent in the DCVAC/OvCa 10. Systemic immunosuppressive therapy for any reason 11. Refusal to sign the informed consent 12. Participation in a clinical trial using experimental therapy within the last 4 weeks prior study entry 13. Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months afterwards 14. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of adding DCVAC/OvCa to Standard of Care chemotherapy on PFS measured at 2 years after randomization in women with ovarian cancer who have undergone debulking surgery;Secondary Objective: •Proportion of patients staying in remission at 6 months after the last dose of first line chemotherapy •Proportion of patients staying in remission at 12 months after the last dose of first line chemotherapy •Biological progression free interval •Immunological response •Proportion of patients requiring second line chemotherapy •Time to second line chemotherapy •OS •Safety •Changes in quality of life (QoL) ;Primary end point(s): Progression free survival (PFS) measured at 2 years after randomization, where PFS is defined as time from randomization to documented disease progression, or death from any cause, whichever occurs earlier and where disease progression is defined as unequivocal progression of any existing lesions or appearance of any new lesion documented by computerized tomography (CT) or magnetic resonance imaging (MRI) scan. The median PFS will be presented if at least 50% of patients progress.;Timepoint(s) of evaluation of this end point: At 2 years after randomization. The median of PFS will be presented if at least 50% of patients progress | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Proportion of patients staying in remission at 6 month after the planned end of first line chemotherapy Proportion of patients staying in remission at 12 months after the planned end of first line chemotherapy OS until End of Study (EOS).;Secondary end point(s): •Proportion of patients staying in remission at 6 months after the planned end of first line chemotherapy •Proportion of patients staying in remission at 12 months after the planned end of first line chemotherapy •Biological progression free interval defined by increasing CA 125 levels (PFIBIO) (Gynecologic Cancer Intergroup [GCIG]: http://www.gcig.igcs.org/CA125/respdef_nov2005.pdf) •Immunological response – detection of entire anti-tumor response (samples to be collected and frozen) •Proportion of patients requiring second line chemotherapy treatment •Time to second line therapy therapy (after the last dose of first line chemotherapy) •OS until End of Study (EOS). The OS for all randomized patients in this study will be analyzed 5 years after the randomization of the last patient in study part 2 or at least 50% maturity is reached, whichever occurs earlier. Adverse Events (AEs), including laboratory abnormalities Evaluation of QoL using standardized FACT-O (Functional Assessment of Cancer Therapy-Ovarian) questionnaire | — |
Countries
Czech Republic, Germany, Poland
Contacts
Public ContactClinical Trials Sotio
SOTIO a.s.
Outcome results
None listed