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
Study ID
NCT07676890
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 NeoOVIV — DRUG
    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.
  • Medium dose NeoOVIV — DRUG
    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.
  • High dose NeoOVIV — DRUG
    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.

Study Details

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 Dates

First listed
Jun 30, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

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

Arms

  • Experimental: Vaccine group
    Participants in this arm will receive standard postoperative adjuvant therapy, tislelizumab, and the personalized NeoOVIV mRNA-lipid nanoparticle vaccine. Standard adjuvant chemotherapy will start approximately 4 weeks after surgery according to current clinical guidelines. Tislelizumab, a PD-1 antibody, will start approximately 10 weeks after surgery and will be administered for 4 doses, generally 1 day before the corresponding chemotherapy cycle. The NeoOVIV vaccine will start approximately 10 weeks after surgery and will be administered by intramuscular injection. 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. Each participant will receive 9 planned vaccine doses in total

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events Assessed by CTCAE Version 5.0 [ Time Frame: From the first dose of study treatment through the last follow-up, up to 18 months ]

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