Clinical trial NCT02107378: Efficacy of DCVAC/OvCa Plus Standard of Care in Relapsed Platinum Resistant Epithelial Ovarian Carcinoma
Official title: A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial Evaluating Effect of Addition of DCVAC/OvCa to Standard Chemotherapy in Women With Relapsed Platinum (Pt)-Resistant Epithelial Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epithelial Ovarian Carcinoma
Keywords: Immunotherapy
Serous
Relapsed
Platinum resistant (pt)
Ovarian Cancer (OvCa)
Biological
Vaccine
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 22
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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (all cause mortality)
timeFrame: 72 weeks
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 72 weeks
measure: Objective Response Rate
timeFrame: 0, 8, 16, ,24, 32, 40, 48, 56, 64, 72 weeks
measure: Biological Progression Free Interval
timeFrame: 0, 8, 16, 24, 32, 40, 48, 56, 64, 72 weeks
measure: Immunological Response
timeFrame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 weeks
measure: Frequency of Adverse Events
timeFrame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
measure: Evaluation of Quality of Life via Functional Assessment of Cancer Therapy-Ovarian
timeFrame: 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 56, 64, 72 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Nový Jičín
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Prague
country: Czech Republic
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: