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NOT YET RECRUITING
NCT07676890
PHASE1

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

This is a Phase I, single-arm, open-label, dose-escalation study in patients with stage II or III ovarian cancer after surgery. The study will evaluate the safety, tolerability, immune response, and preliminary clinical activity of NeoOVIV, a personalized mRNA-lipid nanoparticle vaccine, when given with standard adjuvant chemotherapy and a PD-1 antibody.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-07-31

Completion Date

2028-05-30

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

Low Dose NeoOVIV

Participants will receive the personalized NeoOVIV mRNA-lipid nanoparticle vaccine at a dose of 25 μg, corresponding to an approximate injection volume of 0.2 mL, by intramuscular injection. Vaccination will start approximately 10 weeks after surgery. Each participant will receive 9 planned vaccine doses: 4 priming doses given once every 3 weeks during chemotherapy, followed by 5 booster doses given weekly at weeks 22, 23, 24, 25, and 26 after surgery. Standard adjuvant chemotherapy will start approximately 4 weeks after surgery according to current clinical guidelines. Tislelizumab will start approximately 10 weeks after surgery and will be given for 4 doses, generally 1 day before the corresponding chemotherapy cycle.

DRUG

Medium dose NeoOVIV

Participants will receive the personalized NeoOVIV mRNA-lipid nanoparticle vaccine at a dose of 50 μg, corresponding to an approximate injection volume of 0.4 mL, by intramuscular injection. Vaccination will start approximately 10 weeks after surgery. Each participant will receive 9 planned vaccine doses: 4 priming doses given once every 3 weeks during chemotherapy, followed by 5 booster doses given weekly at weeks 22, 23, 24, 25, and 26 after surgery. Standard adjuvant chemotherapy will start approximately 4 weeks after surgery according to current clinical guidelines. Tislelizumab will start approximately 10 weeks after surgery and will be given for 4 doses, generally 1 day before the corresponding chemotherapy cycle.

DRUG

High dose NeoOVIV

Participants will receive the personalized NeoOVIV mRNA-lipid nanoparticle vaccine at a dose of 100 μg, corresponding to an approximate injection volume of 0.8 mL, by intramuscular injection. Vaccination will start approximately 10 weeks after surgery. Each participant will receive 9 planned vaccine doses: 4 priming doses given once every 3 weeks during chemotherapy, followed by 5 booster doses given weekly at weeks 22, 23, 24, 25, and 26 after surgery. Standard adjuvant chemotherapy will start approximately 4 weeks after surgery according to current clinical guidelines. Tislelizumab will start approximately 10 weeks after surgery and will be given for 4 doses, generally 1 day before the corresponding chemotherapy cycle.