Clinical trial · Interventional
NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
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
NCT05773859CI-TRIAL-00097459NEODOCrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| XP-DC vaccinations | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XP-DC vaccinations
- description
- Patients in this arm will receive XP-DC vaccination in addition to standard-of-care treatment.
- interventionNames
- Biological: XP-DC vaccinations
Primary outcomes (1)
- measure
- Number of patients with an immunological response to XP-DC vaccination
- timeFrame
- At DTH skin test after the second vaccination (approximately study week 10)
- description
- Immunologically responding patients are defined as: T cells isolated from vaccine challenged sites (DTH biopsies) that can be expanded and 1) express T cell receptors specific for the vaccine and 2) show effector functions measured by IFN-gamma secretion or cytolytic activity against tumor antigen expressing target cells. Immunologically non-responding patients are defined as: No T cells, or T cells isolated from DTH biopsies that cannot be expanded, or T cells that can be expanded but do not recognize tumor antigens, or can recognize tumor antigens but do not display T effector functions i.e. lysis of tumor cell targets or release of IFN-α.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 Exclusion criteria * 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)
References
Publications (1)
- DERIVEDKoeneman B, Schreibelt G, Duiveman-de Boer T, Bos K, van Oorschot T, Pots J, Scharenborg N, de Boer A, Hins-de Bree S, de Haas N, de Goede A, Westdorp H, van Ham M, de Vries IJM, Ottevanger PB. NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands. BMJ Open. 2025 Nov 9;15(11):e102184. doi: 10.1136/bmjopen-2025-102184. PMID 41213670