Clinical trial NCT02107937: Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
Official title: A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Ovarian Epithelial Cancer
Keywords: serous
endometrioid
mucinous
epithelial ovarian cancer
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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 \[for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy\]
* Previous or concurrent 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
* 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

Primary outcomes:
measure: Overall progression free survival (PFS)
timeFrame: 104 weeks
Secondary outcomes:
measure: Proportion of patients in remission after first line chemotherapy at 6 months
timeFrame: 0,10, 18, 30, 42 weeks
measure: Proportion of patients in remission after first line chemotherapy at 12 months
timeFrame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
measure: Biological progression free interval
timeFrame: 0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks
measure: Immunological Response
timeFrame: 0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks
measure: Proportion of patients requiring 2nd line chemotherapy
timeFrame: 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
measure: Frequency of Adverse Events
timeFrame: 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
measure: Time to 50 percent survival
timeFrame: 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
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Brno
country: Czechia
city: Hradec Králové
country: Czechia
city: Nový Jičín
country: Czechia
city: Olomouc
country: Czechia
city: Ostrava
country: Czechia
city: Plzeň
country: Czechia
city: Praha 5
country: Czechia
city: Praha
country: Czechia
city: Praha
country: Czechia
city: České Budějovice
country: Czechia
city: Bialystok
country: Poland
city: Lublin
country: Poland
Study officials:
affiliation: SOTIO a.s.
name: Harald Fricke, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hensler M, Rakova J, Kasikova L, Lanickova T, Pasulka J, Holicek P, Hraska M, Hrnciarova T, Kadlecova P, Schoenenberger A, Sochorova K, Rozkova D, Sojka L, Drozenova J, Laco J, Horvath R, Podrazil M, Hongyan G, Brtnicky T, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Garg AD, Cibula D, Bartunkova J, Spisek R, Fucikova J. Peripheral gene signatures reveal distinct cancer patient immunotypes with therapeutic implications for autologous DC-based vaccines. Oncoimmunology. 2022 Jul 22;11(1):2101596. doi: 10.1080/2162402X.2022.2101596. eCollection 2022.
citation: Fucikova J, Hensler M, Kasikova L, Lanickova T, Pasulka J, Rakova J, Drozenova J, Fredriksen T, Hraska M, Hrnciarova T, Sochorova K, Rozkova D, Sojka L, Dundr P, Laco J, Brtnicky T, Praznovec I, Halaska MJ, Rob L, Ryska A, Coosemans A, Vergote I, Cibula D, Bartunkova J, Galon J, Galluzzi L, Spisek R. An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors. Clin Cancer Res. 2022 Jul 15;28(14):3053-3065. doi: 10.1158/1078-0432.CCR-21-4413.
citation: Rob L, Cibula D, Knapp P, Mallmann P, Klat J, Minar L, Bartos P, Chovanec J, Valha P, Pluta M, Novotny Z, Spacek J, Melichar B, Kieszko D, Fucikova J, Hrnciarova T, Korolkiewicz RP, Hraska M, Bartunkova J, Spisek R. Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. J Immunother Cancer. 2022 Jan;10(1):e003190. doi: 10.1136/jitc-2021-003190.