PEP-DC and OC-DC Vaccine in High Grade Serous Ovarian Carcinoma (NCT05714306) | Clinical Trial Compass
WithdrawnPhase 1/2
PEP-DC and OC-DC Vaccine in High Grade Serous Ovarian Carcinoma
Stopped: Lack of funding
0Started 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Signed Informed Consent Form
✓. Histologically confirmed diagnosis of advanced, FIGO stage III or IV, high grade serous ovarian carcinoma (HGSOC)
✓. Underwent PDS or IDS without macroscopic residual disease, (R0)
✓. a. Received at least 3 cycles of peri-operative platinum-based chemotherapy before IDS, with the intention to complete at least 6 cycles of peri-operative platinum-based chemotherapy.
✓. Tumor material is available and sufficient for both OC-DC preparation and identification of Top 10 personalized peptides (PEPs) required for PEP-DC vaccine preparation.
✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Willing and able to comply with study procedures
Exclusion criteria
✕. A secondary debulking surgery is foreseen.
What they're measuring
1
Immunogenicity of OC-DC + PEP-DC vaccine vs. PEP-DC vaccine
Timeframe: through study completion, an average of 7 years
. Prior exposure to anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) and anti-Programmed cell Death 1 (PD1) / anti-Programmed cell Death Ligand (PD-L1) antibodies or other immunotherapy.
✕. Woman of child-bearing potential (WOCBP). By definition, all patients with HGSOC of FIGO stage III to IV who have undergone PDS or IDS, will have undergone total hysterectomy with bilateral salpingo-oophorectomy, and will therefore be women without child-bearing potential. Therefore, no pregnancy tests have to be performed because no WOCBP will be enrolled in this trial.
✕. Breastfeeding women
✕. Other malignancy within 2 years prior to randomization, except for those (for example ductal carcinoma in situ of breast and cervical intraepithelial neoplasia) treated with curative intent. Patients with a predicted 5-year recurrence-free survival rate ≥95% can be included at the investigator's discretion.
✕. Patients with diagnosis of paraneoplastic syndrome.
✕. Current, recent (within 4 weeks prior to randomization), or planned participation in an experimental drug study.
✕. Patient has a serious, non-healing wound, ulcer, or bone fracture.