Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
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