Ovariancancer/ ovarian carcinoma
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Primary epithelial OC patients whom are treated with neoadjuvant chemotherapy, carboplatin/paclitaxel, and subsequent surgery. - Age * 18 years - Signed informed consent in accordance with institutional and regulatory guidelines - Life expectancy * 5 months - Adequate access of the tumor for image guided biopsy - Adequate(according to the instiutional standards) hematology, liver and kidney function to undergo chemotherapy with carboplatin and paclitaxel
Exclusion criteria
Exclusion criteria: or any other systemic intercurrent disease or condition that might affect the immunocompetence of the patient, or treatment with systemic highly immunosuppressive therapy (e.g. transplant recipients or patients who underwent a splenectomy) - Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or p.o. > 7,5 mg / day). - Neurological toxicity > grade 1 at screening - History of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the serous OC type - Pregnancy - Participation in a trial with another investigational drug within 30 days prior to the enrolment in this trial - Any condition that in the opinion of the investigator could interfere with the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether the RNA-LPX OC vaccine induces a vaccine-specific immune response (systemic & local) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of intravenous RNA-LPX OC vaccination in combination with carboplatin and paclitaxel by monitoring and evaluation of adverse events. | — |
Countries
Netherlands
Outcome results
None listed