PEP-DC and OC-DC Vaccine in High Grade Serous Ovarian Carcinoma
Status:
Not yet recruiting
Trial end date:
2030-03-01
Target enrollment:
Participant gender:
Summary
Single center, phase I/II randomized 2-arm study, evaluating two different vaccination
regimens combined with low-dose cyclophosphamide in patients with advanced high grade serous
ovarian carcinoma (HGSOC):
- Arm A patients will be vaccinated with a personalized peptide vaccine comprised of
autologous monocyte-derived dendritic cells (moDC) loaded with patient-specific peptides
(PEP-DC1 vaccine) identified a priori at screening (8 patients);
- Arm B patients will be vaccinated with a personalized tumor lysate vaccine comprising
autologous moDC loaded with patient-specific autologous oxidized tumor lysate (OC-DC
vaccine), followed by PEP-DC2 vaccine comprised of autologous moDC loaded with up to 10
patient-specific peptides identified midway through OC-DC vaccination (8 patients).
In both arms, patients will receive a low dose cyclophosphamide the day before vaccination.
Patients will be vaccinated after the end of adjuvant platinum-based chemotherapy, until
vaccine exhaustion, disease recurrence, major toxicity or patient withdrawal, whichever is
earlier.