Ovarian cancer treatment with a liposome formulated mRNA Vaccine in combination with neo-adjuvant chemotherapy

Withdrawn

Conditions: Ovariancancer/ ovarian carcinoma
10038594
10033283

Registration Number: NL-OMON46832

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess whether the RNA-LPX OC vaccine induces a vaccine-specific immune<br /><br>response (systemic & local)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of intravenous RNA-LPX OC vaccination in<br /><br>combination with carboplatin and paclitaxel by monitoring and evaluation of<br /><br>adverse events. </p><br>