Evaluation and efficacy and safety of DCVAC/OvCa (ovarian cancerimmunotherapy) in woman with relapsed platinum resistant epithelial ovarian carcinoma
- Conditions
- epithelial ovarian carcinomaMedDRA version: 19.0Level: 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-PL
- 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 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)
3. 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 are
selected to receive second line Standard of Care chemotherapy
4. Patients must have at least one measureable target lesion as defined
by
the RECIST 1.1 criteria
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 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
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 Investigators
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
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
? 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
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
- Secondary Outcome Measures
Name Time Method