{
  "abstract": "Introduction The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1).Methods and analysis We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes <1 cm) requiring neoadjuvant chemotherapy will receive DC therapy alongside standard-of-care carboplatin/paclitaxel chemotherapy and interval cytoreductive surgery. The primary endpoint is immune response, and the secondary endpoints are the safety and feasibility of the treatment as well as clinical efficacy.Ethics and dissemination Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences.Trial registration number NCT05773859; EUCT number 2024-512353-24-01.",
  "authors": [
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands",
        "Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Bouke Koeneman"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Gerty Schreibelt"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Tjitske Duiveman - de Boer"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Kevin Bos"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Tom van Oorschot"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Jeanette Pots"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Nicole Scharenborg"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Annemiek de Boer"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Simone Hins - de Bree"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Nienke de Haas"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Pharmacology and Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Anna de Goede"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Harm Westdorp"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Maaike van Ham"
    },
    {
      "affiliations": [
        "Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "I Jolanda M de Vries"
    },
    {
      "affiliations": [
        "Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands"
      ],
      "name": "Petronella B Ottevanger"
    }
  ],
  "title": "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",
  "uid": "6eb90a51-e980-5299-b281-2d7ef0c0fd8d"
}