Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
FEMALE
NCT05773859

NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

Led by Radboud University Medical Center · Updated on 2025-11-18

10

Participants Needed

1

Research Sites

197 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years old with histologically confirmed primary epithelial ovarian cancer.
  • Not eligible for primary debulking surgery and requiring neoadjuvant chemotherapy with interval debulking.
  • High-grade or low-grade serous histology.
  • FIGO stage IIIb, IIIc, IVa, or IVb with lymph nodes 1cm above the diaphragm or in the groins.
  • Extensive abdominal tumor spread.
  • WHO/ECOG performance status 0-1.
  • Neutrophils >1.5 x 10^9/L, platelets >100 x 10^9/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 (except Gilbert's syndrome).
  • Expected adequate follow-up.
  • Postmenopausal or evidence of non-childbearing status, or negative pregnancy test within 28 days prior to treatment and confirmed on day 1.
  • Informed consent given.
Not Eligible

You will not qualify if you...

  • Recurrent ovarian cancer.
  • Histologies other than high-grade serous ovarian cancer (e.g., endometrioid, mucinous, clear cell, carcinosarcoma).
  • Unable 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 >1 cm above the diaphragm or in the groins.
  • History of other malignancies except treated basal cell carcinoma, cervical cancer >5 years ago, or early-stage breast cancer >10 years ago.
  • Serious clinical conditions interfering with safe vaccine administration.
  • Heart failure NYHA class III or IV.
  • Uncontrolled comorbidities including psychiatric or social conditions interfering with participation.
  • Unable to undergo tumor biopsy.
  • Pregnancy or insufficient contraception if reproduction possible.
  • Active hepatitis B, C, HIV, or syphilis infection.
  • Serious other active infections.
  • Known allergy to shellfish.
  • Autoimmune disease except vitiligo.
  • History of organ transplants.
  • Chronic systemic immunosuppressive treatment exceeding 10 mg prednisolone equivalent.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands, 6500 HB

Actively Recruiting

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Research Team

B

Bouke Koeneman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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