NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
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.
| Condition(s) | Epithelial Ovarian Cancer, Ovarian Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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: n |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Radboud University Medical Center |
| Locations | Nijmegen, Gelderland, Netherlands |
| Start date | 2023-03-17 |
| NCT ID | NCT05773859 |
| Official listing | https://clinicaltrials.gov/study/NCT05773859 |