Ovarian cancer ovarian carcinoma
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic induction / expansion of vaccine antigen-specific T cells | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Intratumoral induction / expansion of vaccine antigen-specific T cells 2) Progression-free survival of primary OC patients treated with the vaccines in combination with carboplatin/paclitaxel 3) Assessing the safety and tolerability of repetitive doses of the vaccine in combination with carboplatin/paclitaxel | — |
Countries
Netherlands
Outcome results
None listed