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

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.

Trial Details

NCT ID

NCT07676890

Phase

PHASE1

Sponsor

West China Hospital

Status

RECRUITING

Cancer Type

Ovarian Cancer

Interventions

Low Dose NeoOVIV
Medium dose NeoOVIV
High dose NeoOVIV

Locations (sample)

Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

Female, aged between 18 and 75 years (inclusive) at the time of signing the written informed consent form (ICF)
Patients with histopathologically confirmed epithelial ovarian cancer (EOC), including: a) Patients with Stage II (Stage IIA/IIB, tumor confined to…
In accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, postoperative contrast-enhanced pelvic MRI/CT shows no ma…
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1 (0: Fully ambulatory, no restriction in daily activities; 1: Ambu…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Ovarian Cancer Trials on Trialify →