NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

NCT ID: NCT05773859

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-17
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Epithelial Ovarian Cancer; Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XP-DC vaccinations

Patients in this arm will receive XP-DC vaccination in addition to standard-of-care treatment.

Group Type: EXPERIMENTAL

XP-DC vaccinations

Intervention Type: BIOLOGICAL

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

Interventions

XP-DC vaccinations

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

Intervention Type: BIOLOGICAL

Other Intervention Names

dendritic cell vaccine; cdc1

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelleke Ottevanger, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Bouke Koeneman, MD

Role: CONTACT

bouke.koeneman@radboudumc.nl

+31 (0)24 361 76 00

Facility Contacts

Bouke Koeneman, MD

Role: primary

bouke.koeneman@radboudumc.nl

+31243617600

Nelleke Ottevanger, MD, PhD

Role: backup

nelleke.ottevanger@radboudumc.nl

+31243618800

References

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.

Reference Type: DERIVED

PMID: 41213670 (View on PubMed)

Other Identifiers

NEODOC

Identifier Type: -

Identifier Source: org_study_id