Induction of Neo-Antigen Specific Cytotoxic T Cells by Autologous Tumor Lysate-loaded Specialized Cross-Presenting Dendritic Cells in Epithelial Ovarian Cancer Patients Treated With Neoadjuvant Chemotherapy, the NEODOC Study

NEODOC

This goal of this single arm, single center, exploratory phase I/II clinical trial is to learn more about the immunological efficacy, safety and feasibility of an autologous tumor lysate-loaded autologous XP-DC (cDC1)-based vaccine in patients with ovarian cancer.

2023-03-17

2024-10-01

2024-10-01

Recruiting

Early phase I

10

Inclusion Criteria: * Women over 18 years old with histologically confirmed primary epithelial ovarian cancer. * Not amenable by primary debulking surgery and in need of neoadjuvant chemotherapy and interval debulking * High-grade serous histology * FIGO stage IIIc or FIGO stage IIIb with extensive abdominal spread * WHO/ECOG performance status 0-1 * Neutrophils \>1.5x 109/L lymphocytes \>0.8x 109/L, platelets \>100x 109/L, hemoglobin \>5,6 mmol/L (9.0 g/dl), estimated glomerular filtration rate \> 45 ml/min/1.73m2, AST/ALT \<3 x ULN, serum bilirubin \<1.5 x ULN (exception: Gilbert's syndrome is permitted) * Expected adequacy of follow-up * Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as 1) Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments or 2) surgical sterilisation (bilateral oophorectomy or hysterectomy). * Informed consent Exclusion Criteria: * Recurrent ovarian cancer * Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, low-grade serous, mucinous, clear cell or carcinosarcoma * Unable and/or unwilling to undergo standard chemotherapy and interval debulking surgery * FIGO stage I-IIb, stage IIIa, stage IV * History of any second malignancy, with the exception of adequately treated basal cell carcinoma * Any serious clinical condition that may interfere with the safe administration of DC vaccinations * Heart failure (NYHA class III/IV) * Any uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation * Unable to undergo a tumor biopsy * Pregnancy or insufficient anti-conception if reproduction is still possible * Active infection of Hepatitis B, C, HIV and syphilis * Serious other active infections * Known allergy to shell fish * Auto immune disease (exception: vitiligo is permitted) * History of organ allografts * Chronic treatment with systemic immunosuppressive drugs (i.e. more than 10 mg prednisolone equivalent)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2023-07-12