Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma
Phase 2
Terminated
- Conditions
- Epithelial Ovarian Carcinoma
- Interventions
- Drug: Standard of Care (Paclitaxel or topotecan or doxorubicin)Biological: DCVAC/OvCa
- Registration Number
- NCT02107378
- Lead Sponsor
- SOTIO a.s.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (Chemotherapy) Standard of Care (Paclitaxel or topotecan or doxorubicin) Standard of Care as an Active Comparator (Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy) DCVAC/OvCa in parallel with chemo (SoC) DCVAC/OvCa Combination therapy with DCVAC/OvCa and Standard of Care (SoC)
- Primary Outcome Measures
Name Time Method Overall survival (all cause mortality) 72 weeks
- Secondary Outcome Measures
Name Time Method Progression Free Survival 72 weeks Per modified RECIST
Objective Response Rate 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks Per RECIST
Immunological Response 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks Biological Progression Free Interval 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks 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