Phase I study to evaluate safety and systemic immunogenicity of the DCP-001 vaccine in patients with high grade serous ovarian cancer after primary treatment.
This is a first phase I study in HGSOC patients with primary disease eligible for standard of care treatment with either; complete or optimal primary cytoreductive surgery followed by 6 cycles of adjuvant chemotherapy (carboplatin/paclitaxel); or 3 cycles of neoadjuvant chemotherapy (carboplatin/paclitaxel) followed by complete or optimal cytoreductive interval surgery and 3 additional cycles carboplatin/paclitaxel. In the current study, DCP-001 vaccinations will be scheduled after standard of care treatment, starting 6 weeks after the last cycle of chemotherapy. Patients will receive 4 vaccinations containing 25E6 DCP-001 cells per vaccination followed by 2 additional booster vaccinations of 10E6 cells. Each patient will be followed up for 24 months. Safety will be monitored throughout the study. Systemic immune responses are determined by standard immune assays using peripheral blood mononuclear cells (PBMCs) and serum collected before, during and after vaccinations. Progression of disease will be monitored according to standard-of-care follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
allogeneic dendritic cell vaccine
UMCG
Groningen, Provincie Groningen, Netherlands
Change from baseline DCP_001 vaccine antigen-specific T cells in the peripheral blood (systemic induction / expansion of DCP_001 vaccine antigen-specific T cells)
Systemic DCP-001 vaccine specific response is measured by the number of patients with de novo or increased immune responses based on IFNƴ ELISpot assay in any or more of the post-vaccination PBMC samples to at least one of the following DCP-001 vaccine antigens compared to baseline: WT-1, Survivin, RHAMM or PRAME, specific cancer testis antigens as NY-ESO1 and MAGE3.
Time frame: A PBMC collection is planned at baseline, before start treatment. Further PBMC collections are scheduled during (4 times) and after the vaccinations.
Safety and tolerability of the repetitive doses of the DCP-001 vaccine
Number of patients with AEs, and SAEs
Time frame: Up to 28 days after last vaccination
Recurrence free survival (RFS)
RFS defined as the number of patients alive without any progress or recurrence (local or regional, or distant) and death due to any cause
Time frame: Up to 2 years from disease diagnosis
Overall survival (OS)
OS defined as the number of patients alive, measured in months, up to 2 years from disease diagnosis.
Time frame: Up to 2 years from disease diagnosis
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