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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- Primary epithelial OC patients with measurable tumor lesions (determined by
CT or MRI), who are intended to be treated with neo-adjuvant chemotherapy,
carboplatin/paclitaxel, subsequent surgery and adjuvant chemotherapy
- Age >= 18 years
- Signed informed consent in accordance with institutional and regulatory
guidelines
- Adequate access of the tumor for image-guided biopsy
- Adequate (according to the institutional standards) hematology, liver and
kidney function to undergo chemotherapy with carboplatin and paclitaxel
- ECOG-performance status of 0 or 1 at screening
- Current BMI > 18.5 and no weight loss of >5% over the past month. Notably,
weight loss due to drainage of ascites is not applicable.

Exclusion Criteria

- History of a second malignancy except for curatively treated low-stage tumors
with a histology that can be differentiated from the epithelial OC type

-Patients must have no ongoing or recent evidence (within the last 5 years) of
significant autoimmune disease that required treatment with systemic
immunosuppressive treatments which may suggest risk for immune-related adverse
events (irAEs).
Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related
hypothyroidism who are in remission, or on a stable dose of thyroid-replacement
hormone, vitiligo, or psoriasis may be included.

- Patients must have no uncontrolled infection with human immunodeficiency
virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
that is related to, or results in chronic infection. Mild cancer-related
immunodeficiency (such as immunodeficiency treated with gamma globulin and
without chronic or recurrent infection) is allowed.
o Patients with known HIV who have controlled infection (undetectable viral
load and CD4 count above 350 either spontaneously or on a stable antiviral
regimen) are permitted. For patients with controlled HIV infection, monitoring
will be performed per local standards.
o Patients with known hepatitis B (HepBsAg+) who have controlled infection
(serum hepatitis B virus DNA PCR that is below the limit of detection AND
receiving antiviral therapy for hepatitis B) are permitted. Patients with
controlled infections must undergo periodic monitoring of HBV DNA per local
standards. Patients must remain on anti-viral therapy for at least 6 months
beyond the last dose of trial treatment.
o Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have
controlled infection (undetectable HCV RNA by PCR either spontaneously or in
response to a successful prior course of anti-HCV therapy) are permitted.

- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
p.o. >7.5 mg / day).
- Pregnancy or breast feeding
- 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>Systemic induction / expansion of vaccine antigen-specific T cells</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Intratumoral induction / expansion of vaccine antigen-specific T cells<br /><br>2) Progression-free survival of primary OC patients treated with the vaccines<br /><br>in combination with carboplatin/paclitaxel<br /><br>3) Assessing the safety and tolerability of repetitive doses of the vaccine in<br /><br>combination with carboplatin/paclitaxel</p><br>

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