Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCVAC/OvCa with Standard of Care DCVAC/OvCa in parallel with chemotherapy (Standard of Care) |
Biological: DCVAC/OvCa with Standard of Care
DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
Other Names:
|
| Experimental: DCVAC/OvCa sequentially chemotherapy DCVAC/OvCa sequentially after chemotherapy |
Biological: DCVAC/OvCa sequentially chemotherapy
DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
Other Names:
|
| Active Comparator: Standart of Care Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy |
Drug: Standard of Care
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall progression free survival (PFS) [104 weeks]
Secondary Outcome Measures
- Proportion of patients in remission after first line chemotherapy at 6 months [0,10, 18, 30, 42 weeks]
- Proportion of patients in remission after first line chemotherapy at 12 months [0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks]
- Biological progression free interval [0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks]
- Immunological Response [0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks]
- Proportion of patients requiring 2nd line chemotherapy [0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks]
- Frequency of Adverse Events [0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks]
- Time to 50 percent survival [0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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]
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Previous or concurrent radiotherapy to the abdomen and pelvis
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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
-
Clinically significant cardiovascular disease including:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brno | Czechia | 625 00 | ||
| 2 | Brno | Czechia | 656 53 | ||
| 3 | Hradec Králové | Czechia | 500 05 | ||
| 4 | Nový Jičín | Czechia | 741 01 | ||
| 5 | Olomouc | Czechia | 775 20 | ||
| 6 | Ostrava | Czechia | 708 52 | ||
| 7 | Plzeň | Czechia | 304 60 | ||
| 8 | Praha 5 | Czechia | 150 06 | ||
| 9 | Praha | Czechia | 100 34 | ||
| 10 | Praha | Czechia | 128 08 | ||
| 11 | České Budějovice | Czechia | 370 01 | ||
| 12 | Bialystok | Poland | 15-276 | ||
| 13 | Lublin | Poland | 20-090 |
Sponsors and Collaborators
- SOTIO a.s.
Investigators
- Study Director: Harald Fricke, MD, PhD, SOTIO a.s.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SOV01
- 2013-001322-26