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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud universitair medisch centrum

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 31 Dec 2025

Decision date (initial)

2024-11-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512353-24-01

EudraCT number

2021-000714-42

ClinicalTrials.gov

NCT05773859

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Conditions and MedDRA coding

Ovarian cancer

Regulatory references

Plan to share IPD

Yes

IPD plan description

De-identified individual participant data (IPD) will be made available through the Radboud Data Repository (RDR) under restricted access conditions. Metadata describing the dataset will be publicly accessible to support findability and transparency. Access to the IPD will be granted to qualified researchers upon request, subject to review and approval by a designated data access committee. Data will be shared in accordance with the FAIR principles (Findable, Accessible, Interoperable, Reusable), Radboudumc Research Data Management Policy, and GDPR requirements. All shared data will be pseudonymized or anonymized to ensure participant privacy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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

Exclusion criteria 1

1. • 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is the immune response enhanced or induced by autologous tumor lysate-loaded XP-DC in epithelial ovarian cancer patients.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

Sponsor organisation

Stichting Radboud universitair medisch centrum

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Bouke Koeneman

Public contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Bouke Koeneman

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications