Clinical trial NCT02107950: Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
Official title: A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Neoplasms
Ovarian Cancer (OvCa)
Ovarian Epithelial Cancer
Keywords: Ovarian
Platinum Sensitive
Epithelial
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 71
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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Determine median progression free survival
timeFrame: 72 Week
Secondary outcomes:
measure: Overall survival (all causes)
timeFrame: 56, 64, 72 weeks
measure: Objective Response Rate
timeFrame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
measure: Biological Progression Free Interval
timeFrame: 6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks
measure: Immunological Response
timeFrame: 24, 48, 72 weeks
measure: Frequency of adverse events
timeFrame: 8, 16, 24, 32, 40, 48, 56. 64. 72 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Brno
country: Czechia
city: Ceske Budejovice
country: Czechia
city: Hradec Králové
country: Czechia
city: Nový Jičín
country: Czechia
city: Olomouc
country: Czechia
city: Ostrava
country: Czechia
city: Prague
country: Czechia
city: Praha 5
country: Czechia
city: Cologne
country: Germany
city: Dresden
country: Germany
city: Erlangen
country: Germany
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
Study officials:
affiliation: Accord Research
name: Ales Horacek
role: STUDY_DIRECTOR
References:
citation: Cibula D, Rob L, Mallmann P, Knapp P, Klat J, Chovanec J, Minar L, Melichar B, Hein A, Kieszko D, Pluta M, Spacek J, Bartos P, Wimberger P, Madry R, Markowska J, Streb J, Valha P, Hassan HIB, Pecen L, Galluzzi L, Fucikova J, Hrnciarova T, Hraska M, Bartunkova J, Spisek R. Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. Gynecol Oncol. 2021 Sep;162(3):652-660. doi: 10.1016/j.ygyno.2021.07.003. Epub 2021 Jul 20.