Evaluation and efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in woman with relapsed platinum resistant epithelial ovarian carcinoma
- Conditions
- epithelial ovarian carcinomaMedDRA version: 16.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2013-001325-24-CZ
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
Female aged =18 years
Patients with histologically confirmed, FIGO (Féderation Internationale
de Gynécologie et d’Obstétrique) stage III epithelial ovarian, primary
peritoneal, or fallopian tube carcinoma (serous, endometrioid or
mucinous), who have undergone initial or interval debulking surgery
but have not reached complete remission of more than 6 months after
first line Platinum (Pt) based chemotherapy, for one of the following
reasons:
Patients are Pt-refractory (no response)
Complete remission was not reached (partial responders)
Relapse within =6 months of remission (Pt-resistant)
Pt-based chemotherapy failure should have been confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) scan (Pt-resistant) or by finding described as ‘did not reach complete clinical remission’ (Pt-refractory or Pt-partial response)
Patients must have at least one measureable target lesion as defined by
the RECIST 1.1 criteria
Laboratory criteria (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
Neutrophil count >1,500/mm3 (1.5 x109/L)
Hemoglobin of at least 10g/dL (100g/L)
Platelet count of at least 100,000/mm3 (100 x109/L)
Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted)
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2x upper limit of normal (ULN), serum
creatinine =2.0mg/dL
Blood Urea Nitrogen (BUN) <2.0x ULN
Adequate coagulation parameters (results must be obtained <14 days before randomization, including results obtained before giving
informed consent):
Activated partial thromboplastin time (APTT) =1.5x ULN and
International Normalized Ratio (INR) =1.5
Life expectancy of at least 12 months based on Investigators judgment
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Signed informed consent including patient’s ability to comprehend its
contents
Females of childbearing potential must have had a negative serum
pregnancy test at screening (ß-human chorionic gonadotropin [ß-HCG])
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
FIGO I,II,IV epithelial ovarian cancer
FIGO III 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 Pt-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 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% or serious cardiac conduction system
disorders, if a pacemaker is not present Pleural and pericardial effusion of any National Cancer Institute
(NCI) common terminology criteria for adverse events (CTCAE)
grade
Peripheral neuropathy having a CTCAE =Grade 2
Active autoimmune disease requiring treatment
History of severe forms of primary immune deficiencies
History or anaphylaxis or other serious reaction following
vaccination
Uncontrolled co-morbidities including, psychiatric or social
conditions which, in the Investigator’s opinion, would prevent
participation in the trial
Known hypersensitivity to any constituent in the DCVAC/OvCa
Systemic immunosuppressive therapy for any reason
Refusal to sign the informed consent
Participation in a clinical trial using experimental therapy within the
last 4 weeks before study entry; patients previously enrolled in protocol
SOV01 who did not receive treatment with DCVAC/OvCa can be
included in this study
Fertile woman of childbearing potential not willing to use adequate
contraception for the study duration and at least six months afterwards
Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of adding DCVAC/OvCa to Standard of Care<br>chemotherapy on OS in women with ovarian cancer who experienced<br>relapse =6 months after achieving complete remission following<br>standard first line (Pt-based) chemotherapy or did not reach complete<br>remission;Secondary Objective: Progression free survival (PFS)<br><br>Objective response rate (ORR) = complete response(CR) + partial<br>response (PR)<br><br>Biological progression free interval<br><br>Immunological response<br><br>Safety<br><br>Changes in quality of life (QoL);Primary end point(s): OS (overall survival) defined as the time from randomization until death due to any cause;Timepoint(s) of evaluation of this end point: Time from randomization until death due to any cause
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PFS measured by modified RECIST (Response Evaluation Criteria In<br>Solid Tumors) criteria version 1.1. PFS is defined as the time from<br>randomization to tumor progression or death from any cause.<br>ORR = CR + PR measured by the RECIST 1.1 criteria<br><br>Biological progression free interval defined by increasing CA 125<br>levels (PFIBIO) (Gynecologic Cancer Intergroup [GCIG]:<br>http://www.gcig.igcs.org/CA125/respdef_nov2005.pdf)<br><br>Immunological response – detection of entire anti-tumor response<br>(samples to be collected and frozen);Timepoint(s) of evaluation of this end point: PFS will be measured at the End of Study and the median PFS will be presented if at least 50% of patients progress.<br>