A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVSV Vaccine in Patients With Ovarian Cancer After Surgery

Sponsor
West China Hospital
Study ID
NCT07724106
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Dose — DRUG
    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.
  • middle dose — DRUG
    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.
  • high dose — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
May 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vaccine group
    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

Primary Outcome Measure

safety assessment [ Time Frame: Throughout treatment, followed up to 18 months after treatment ]

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