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Induction of neo-antigen specific T cells by specialized cross-presenting dendritic cells in epithelial ovarian cancer patients treated with neoadjuvant chemotherapy, the NEODOC study
EU CTIS ID: 2024-512353-24-01
What this study is testing
The primary objective of this phase I/II study is to show immunological efficacy of tumor-lysate loaded XP-DC in EOC patients undergoing (neo-)adjuvant chemotherapy.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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 or low grade serous histology • FIGO stage IIIb, IIIc, IVa or IVb if only lymph nodes ≤ 1cm above the diaphragm or in the groins • Extensive abdominal spread of tumor • WHO/ECOG performance status 0-1 • Neutrophils >1.5x 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: o Amenorrhoeic for 1 year or more following cessation of exogenous hormonal therapy; o or surgical sterilisation (bilateral oophorectomy or hysterectomy). • Informed consent
You likely can't join if
- • Recurrent ovarian cancer • Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, mucinous, clear cell or carcinosarcoma • Unable and/or unwilling to undergo standard chemotherapy and interval debulking surgery • FIGO stage I-IIb, IIIa or IVb with liver, spleen or lung metastases or lymph nodes above the diaphragm or in the groins > 1 cm • History of any second malignancy, with the exception of adequately treated basal cell carcinoma, cervical cancer > 5 years ago or earlystage breast cancer >10 years ago. • 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.