This is a Phase I, single-arm, open-label, prospective, non-randomized, single-center dose-escalation study. The study will evaluate the safety, tolerability, and preliminary activity of the NeoOVSV mRNA-lipid nanoparticle vaccine in patients with stage II/III ovarian cancer after surgery, in combination with standard adjuvant chemotherapy and a PD-1 antibody.
Inclusion Criteria:
Exclusion Criteria:
Open label.
Participants in this single treatment arm will receive standard postoperative adjuvant chemotherapy, tislelizumab as a PD-1 antibody, and the NeoOVSV mRNA-lipid nanoparticle vaccine. Standard adjuvant chemotherapy will begin approximately 4 weeks after surgery, with the regimen selected according to current clinical guidelines, such as paclitaxel plus carboplatin. Tislelizumab will also begin approximately 4 weeks after surgery and will be administered for 6 doses, generally 1 day before chemotherapy. The NeoOVSV vaccine will be administered by intramuscular injection starting approximately 4 weeks after surgery. Three dose levels will be evaluated using a 3+3 dose-escalation design: 25 μg, 50 μg, and 100 μg, corresponding to approximate injection volumes of 0.2 mL, 0.4 mL, and 0.8 mL, respectively. Each dose level will enroll 3 to 6 participants. The vaccine schedule includes 6 priming doses given once every 3 weeks during chemotherapy, followed by 3 booster doses given once weekl
A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVIV Vaccine in Patients With Ovarian Cancer After Surgery
Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy
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