Epithelial Ovarian Carcinoma
Conditions
Keywords
Immunotherapy, Serous, Relapsed, Platinum resistant (pt), Ovarian Cancer (OvCa), Biological, Vaccine
Brief summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy may result in prolongation of Overall Survival (OS).
Detailed description
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).
Interventions
BIOLOGICALDCVAC/OvCa
DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
DRUGStandard of Care (Paclitaxel or topotecan or doxorubicin)
Paclitaxel or topotecan or doxorubicin 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 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
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 * Clinically significant cardiovascular disease * Active autoimmune disease requiring treatment * History of severe forms of primary immune deficiencies * Systemic immunosuppressive therapy for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (all cause mortality) | 72 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks | Per RECIST |
| Biological Progression Free Interval | 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks | — |
| Progression Free Survival | 72 weeks | Per modified RECIST |
| Frequency of Adverse Events | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks | — |
| Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks | — |
| Immunological Response | 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks | — |
Countries
Czechia, Germany, Poland
Outcome results
None listed