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

NCT07724106 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Low Dose

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.

DRUG

middle dose

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.

DRUG

high dose

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-05-01
Completion
2028-05-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07724106 on ClinicalTrials.gov