Dendritic cell vaccination for ovarian cancer treatment

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 study is testing a special vaccine made from immune cells to see if it can help women with advanced ovarian cancer feel better while they receive chemotherapy.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Radboud University Medical Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nijmegen, Gelderland)
• Trial ID: NCT05773859 on ClinicalTrials.gov

What this trial studies

This exploratory phase I/II clinical trial aims to evaluate the immunological efficacy, safety, and feasibility of a specialized dendritic cell vaccine loaded with tumor lysate in patients with epithelial ovarian cancer. The trial will include 10 women with advanced stage III ovarian cancer who are not candidates for primary surgery and require neoadjuvant chemotherapy. The vaccine utilizes a specific type of dendritic cell known as XP-DC, which is designed to enhance immune responses against tumor neoantigens. Participants will receive XP-DC vaccinations while undergoing chemotherapy to assess the potential for improved treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with histologically confirmed high-grade serous epithelial ovarian cancer at stage IIIb, IIIc, IVa, or IVb.

Not a fit: Patients with non-epithelial ovarian cancer or those who are not amenable to neoadjuvant chemotherapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective immunotherapy options for patients with advanced ovarian cancer.

How similar studies have performed: While there have been studies exploring dendritic cell vaccines in other cancers, this specific approach in ovarian cancer is novel and has not been extensively tested.

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)

Where this trial is running

Nijmegen, Gelderland

• Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Nelleke Ottevanger, MD/PhD — Radboud University Medical Center
• Study coordinator: Bouke Koeneman, MD

Conditions: Epithelial Ovarian Cancer, Ovarian Carcinoma, immunotherapy, dendritic cell vaccination, ovarian cancer