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AzTrials

Epithelial Ovarian CancerPhase 1/2NEODOCNCT05773859

NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

A Phase 1/2 study testing XP-DC vaccinations in people with Epithelial Ovarian Cancer and Ovarian Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer, Ovarian Carcinoma
What is being tested?
XP-DC vaccinations
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNetherlands
Study dates
17 Mar 2023to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bouke Koeneman, MD contact

+31 (0)24 361 76 00

bouke.koeneman@radboudumc.nl

Netherlands1 site, 1 recruiting

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6500 HB

    Bouke Koeneman, MD, +31243617600, bouke.koeneman@radboudumc.nl

    Nelleke Ottevanger, MD, PhD, +31243618800, nelleke.ottevanger@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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

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.

Read the detailed description

Epithelial ovarian cancer (EOC) is the deadliest gynecological malignancy worldwide. Despite intensified treatment, 5-year overall survival rates only improved modestly over the last 20 years and remain low at around 30% for patients with advanced disease in the Netherlands. To this day, results from trials with the checkpoint inhibitors, that have revolutionized treatment in other cancer types, have been disappointing in EOC. Therefore, novel effective therapies are long awaited.

Recently, naturally circulating blood -derived dendritic cells (nDC) were shown to be potent in inducing cytotoxic immune responses and tumor regression in cancer patients. An even more specialized DC subset, referred to as cDC1 (conventional Dendritic Cells type 1) or XP-DC (specialized cross presenting DC) have shown their superiority in preclinical models. They are better at inducing cytotoxic T-cell responses against tumors after uptake of necrotic tumor cell material, a phenomenon called cross-presentation. This capability in cross-presentation makes XP-DC an ideal DC type in combination with tumor lysate-loading to induce immune responses against the scarce neoantigens present in EOC tumors.

The objective of this exploratory trial is to investigate the immunological efficacy as well as safety and feasibility of tumor-lysate loaded XP-DC in EOC patients undergoing (neo-)adjuvant chemotherapy. To this end 10 patients with stage III ovarian cancer will be included and offered a combined approach with DC vaccination in addition to standard-of-care chemotherapy and surgery. Extensive monitoring of the immune system throughout the course of the trial will be performed.

Being tested
XP-DC vaccinations
Keywords
immunotherapy, dendritic cell vaccination, ovarian cancer
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XP-DC vaccinationsBiological

    Also called dendritic cell vaccine, cdc1

    Autologous cross-presenting dendritic cells loaded with autologous tumor lysate and KLH

Study groups in NCT05773859
Study groupRoleWhat they receive
XP-DC vaccinationsExperimentalPatients in this arm will receive XP-DC vaccination in addition to standard-of-care treatment.
Receives: Biological: XP-DC vaccinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with an immunological response to XP-DC vaccination

    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.

    Measured: At DTH skin test after the second vaccination (approximately study week 10)

Secondary outcomes (4)

  1. Safety as assessed by incidence of treatment-related adverse events

    Toxicity will be assessed according to CTCAE version 4.03.

    Measured: Throughout the treatment phase until 1 year of follow-up

  2. Feasibility of tumor lysate-loaded XP-DC vaccinations in patients with advanced EOC

    Feasibility assessment will be based on reporting of:

    • the number of patients from whom a successful apheresis product can be obtained
    • the number of patients from whom (both quantitatively and qualitatively) sufficient tumor lysate can be obtained
    • the number of patients for whom a DC product can be manufactured that meets the prespecified criteria
    • the number of patients that has received the planned number of vaccinations.

    Measured: Throughout the treatment phase until the last planned vaccination (approximately study week 23)

  3. Recurrence free survival (RFS) after 12 months

    Percentage of patients alive without recurrence of disease after 12 months

    Measured: 1 year

  4. Number of patients with complete pathological response

    The number of patients with a complete pathological response

    Measured: At time of debulking surgery (approximately study week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start17 Mar 2023
  3. Primary completionMar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773859
Sponsor's protocol ID
NEODOC
Acronym
NEODOC
Status last verified
Oct 2025
First submitted
12 Feb 2023
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD underlying the results in the publication will be made available in an online data repository under restricted access.

Publications

  • Koeneman 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.

    PubMed 41213670

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XP-DC vaccinations in people with Epithelial Ovarian Cancer and Ovarian Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bouke Koeneman, MD (+31 (0)24 361 76 00, bouke.koeneman@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with an immunological response to XP-DC vaccination (time frame: At DTH skin test after the second vaccination (approximately study week 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05773859, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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