NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Epithelial Ovarian Cancer, Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT05773859

Run by

Radboud University Medical Center

People needed

10

Starts

2023-03-17

Expected to finish

2026-12-31

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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:
• Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments;
• or surgical sterilisation (bilateral oophorectomy or hysterectomy).
• Informed consent

You may not qualify 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 early stage 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)

Where it is running

• Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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