Ovarian Cancer (OvCa), Ovarian Epithelial Cancer, Ovarian Neoplasms
Conditions
Keywords
Ovarian, Platinum Sensitive, Epithelial
Brief 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).
Detailed description
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
Interventions
BIOLOGICALDCVAC/OvCa in parallel with chemotherapy
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
DRUGStandard of Care
Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
Sponsors
SOTIO a.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine median progression free survival | 72 Week |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (all causes) | 56, 64, 72 weeks |
| Objective Response Rate | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks |
| Biological Progression Free Interval | 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks |
| Immunological Response | 24, 48, 72 weeks |
| Frequency of adverse events | 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks |
Countries
Czechia, Germany, Poland
Outcome results
None listed