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

NCT07676890 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

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.

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
2028-05-30
Completion
2028-05-30

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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 NCT07676890 on ClinicalTrials.gov