Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy

OLIVIA-UMCG-01

This is a first-in-human, open label phase I study in ovarian cancer patients with primary disease eligible for standard-of-care treatment with neo-adjuvant chemotherapy, i.e. 3 cycles carboplatin/paclitaxel, interval surgery and 3 additional cycles carboplatin/paclitaxel. Eight doses of the W_ova1 vaccine will be administered prior and in combination with the (neo-)adjuvant chemotherapy to induce an anti-tumor immune response. Systemic immune responses are determined using peripheral blood mononuclear cells collected before, during and after vaccinations. Intratumoral accumulation of T-cells recognizing vaccine-encoded TAAs will be determined before vaccination in a tumor biopsy and after the 3 cycles of chemotherapy and the 5th vaccination using tumor tissue derived from interval surgery. \[18F\]FB-IL2 PET-CT will be used for the non-invasive assessment of T-cell activation and correlated to immunohistochemistry tumor tissue data from pre-treatment biopsy and interval debulking surgery

2019-11-25

2023-06-26

2023-06-26

Terminated

Early phase I

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 * History of an autoimmune disease, specifically HAV, HBV, HCV and HIV, 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). * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a first-in-human, open label phase I study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2023-06-29