A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVSV Vaccine in Patients With Ovarian Cancer After Surgery
West China Hospital
9 participants
Sep 10, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants will receive the NeoOVSV mRNA-lipid nanoparticle vaccine at a dose of 25 μg, corresponding to an approximate injection volume of 0.2 mL, administered by intramuscular injection. Vaccination will start approximately 4 weeks after surgery. The vaccine schedule includes 6 priming doses given once every 3 weeks during adjuvant chemotherapy, followed by 3 booster doses given once weekly after chemotherapy. Standard adjuvant chemotherapy will also start approximately 4 weeks after surgery according to current clinical guidelines, such as paclitaxel plus carboplatin. Tislelizumab will be administered for 6 doses, generally 1 day before chemotherapy.
Participants will receive the NeoOVSV mRNA-lipid nanoparticle vaccine at a dose of 50 μg, corresponding to an approximate injection volume of 0.4 mL, administered by intramuscular injection. Vaccination will start approximately 4 weeks after surgery. The vaccine schedule includes 6 priming doses given once every 3 weeks during adjuvant chemotherapy, followed by 3 booster doses given once weekly after chemotherapy. Standard adjuvant chemotherapy will also start approximately 4 weeks after surgery according to current clinical guidelines, such as paclitaxel plus carboplatin. Tislelizumab will be administered for 6 doses, generally 1 day before chemotherapy.
Participants will receive the NeoOVSV mRNA-lipid nanoparticle vaccine at a dose of 100 μg, corresponding to an approximate injection volume of 0.8 mL, administered by intramuscular injection. Vaccination will start approximately 4 weeks after surgery. The vaccine schedule includes 6 priming doses given once every 3 weeks during adjuvant chemotherapy, followed by 3 booster doses given once weekly after chemotherapy. Standard adjuvant chemotherapy will also start approximately 4 weeks after surgery according to current clinical guidelines, such as paclitaxel plus carboplatin. Tislelizumab will be administered for 6 doses, generally 1 day before chemotherapy.
Locations(1)
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NCT07724106