Evaluation of efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in women with relapsed platinum sensitive ovarian carcinoma
- Conditions
- epithelial ovarian carcinomaTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]MedDRA version: 18.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2013-001323-38-DE
- Lead Sponsor
- SOTIO a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
1.Female aged =18 years
2.Patients with histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) stage III and 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
3.Radiologically confirmed relapse after >6 months of remission
(Pt-sensitive patients), found up to 4 weeks prior study entry.
4.The patient must have at least one measureable target lesion as defined by the RECIST 1.1 criteria to be eligible for enrolment in the study
5.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 (Hb) =10g/dL (100g/L)
?Platelet count =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
6.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
7.Life expectancy of at least 12 months based on Investigator’s judgment
8.Eastern Cooperative Oncology Group (ECOG) Performance status 0?2
9.Signed informed consent including patient’s ability to comprehend its contents
10.Females of childbearing potential (assessed by Investigator) 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
1.FIGO I,II epithelial ovarian cancer
2.FIGO III, IV clear cells epithelial ovarian cancer
3.Non-epithelial ovarian cancer
4.Borderline tumors (tumors of low malignant potential)
5.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)
6.Previous or concurrent radiotherapy to the abdomen and pelvis
7.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
8.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
?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
9.Known hypersensitivity to any constituent in the DCVAC/OvCa
10.Systemic immunosuppressive therapy for any reason
11.Refusal to sign the informed consent
12.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
13.Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months afterwards
14.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 explore the effect of adding DCVAC/OvCa to Standard of Care chemotherapy on PFS in women with ovarian cancer who experienced relapse >6 months after complete remission following<br>Pt-based first line chemotherapy;Secondary Objective: Overall survival (OS) <br>Objective response rate (ORR) = complete response(CR) + partial<br>response (PR)<br>Biological progression free interval<br>Immunological response<br>Safety<br>Changes in quality of life (QoL);Primary end point(s): PFS measured by modified RECIST criteria version 1.1. PFS is defined as the time from randomization to tumor progression or death from any cause. PFS will be followed until 72 weeks after 2nd line SoC chemotherapy initiation and the median PFS will be presented if at least 50% of patients progress ;Timepoint(s) of evaluation of this end point: PFS will be followed until 72 weeks after 2nd line SoC chemotherapy initiation and the median PFS will be presented if at least 50% of patients progress
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •OS until End of Study. OS is defined as the time from randomization until death due to any cause<br>•ORR = CR + PR measured by the RECIST criteria<br>•Biological progression free interval defined by increasing CA 125 levels (PFIBIO) <br>• Immunological response – detection of entire anti-tumor response<br>(samples to be collected and frozen)<br>• Adverse Events (AEs), including laboratory abnormalities<br>• Evaluation of QoL using standardized FACT-O questionnaire<br>(Functional Assessment of Cancer Therapy-Ovarian);Timepoint(s) of evaluation of this end point: OS until End of Study<br>Secondary endpoints will be measured at the End of Study