A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenici… (NCT07724106) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Single-Arm, Open-Label, Prospective Study Evaluating the Safety, Tolerability, and Immunogenicity of the NeoOVSV Vaccine in Patients With Ovarian Cancer After Surgery
9 participantsStarted 2026-07-31
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 the pelvis with no extra-abdominal metastasis) or Stage III (Stage IIIA/IIIB/IIIC, tumor involving the serosal surface of intra-abdominal viscera or regional lymph node metastasis) disease, in accordance with the International Federation of Gynecology and Obstetrics (FIGO) 2014 Staging System; b) Have undergone cytoreductive surgery (CRS), with postoperative pathological confirmation of R1 resection (R1 defined as microscopic residual tumor at the surgical margin ≤ 1 mm); c) Qualified tumor tissue obtained during surgery is available for neoantigen screening: ① Fresh tumor tissue ≥ 100 mg (collected on the day of surgery and immediately immersed in RNA stabilization reagent); or ② ≥ 5 unstained sections of formalin-fixed paraffin-embedded (FFPE) tissue (each with a thickness of 5 μm, tumor cellularity ≥ 30%, and no significant necrosis); d) Whole-exome sequencing (WES) combined with RNA sequencing confirms the presence of ≥ 5 "usable neoantigens" (defined as: HLA binding affinity IC50 \< 500 nM, and transcript expression level of the mutant gene in transcripts per million (TPM) ≥ 1);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
safety assessment
Timeframe: Throughout treatment, followed up to 18 months after treatment
. In accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, postoperative contrast-enhanced pelvic MRI/CT shows no macroscopic residual disease (R2 resection), and lung metastasis, liver metastasis, and bone metastasis are excluded;
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1 (0: Fully ambulatory, no restriction in daily activities; 1: Ambulatory and able to perform light physical activity, no significant fatigue or dyspnea), with an expected overall survival of ≥ 1 year;
. Adequate function of major organs, with relevant laboratory test results within 14 days prior to enrollment meeting the following requirements (no blood transfusion or blood product administration, no use of hematopoietic growth factors, albumin, or other blood products during this period): Hematology tests: Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 100 × 10⁹/L; Serum biochemistry tests: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine (SCr) ≤ 1.5 × ULN, or creatinine clearance rate (CrCl) ≥ 50 mL/min calculated by the Cockcroft-Gault formula; Endocrine tests: Thyroid-stimulating hormone (TSH), free triiodothyronine (free T3), and free thyroxine (free T4) are within the normal reference range; Coagulation function tests: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.2 × ULN;
. Women of childbearing potential (WOCBP) must have a negative serum β-human chorionic gonadotropin (β-HCG) test prior to enrollment, and agree to use effective contraceptive measures (e.g., condoms, intrauterine device \[IUD\]) during the study period (from the first dose administration to 6 months after the last dose administration);
. Good treatment compliance, and the patient and their family members agree to cooperate with and complete the scheduled survival follow-up.
Exclusion criteria
. Histopathologically confirmed non-epithelial ovarian cancer, including ovarian germ cell tumors (e.g., teratoma, yolk sac tumor), sex cord-stromal tumors (e.g., granulosa cell tumor), and metastatic ovarian tumors (e.g., Krukenberg tumor metastatic to the ovary from the gastrointestinal tract);
. R2 resection (macroscopic residual disease) after cytoreductive surgery, or postoperative imaging (contrast-enhanced pelvic MRI/CT, chest CT) showing distant metastasis (e.g., lung, liver, brain metastasis), or FIGO stage IV disease;
. Prior treatment with any therapeutic cancer vaccine (e.g., peptide vaccine, DNA vaccine, other mRNA vaccines); or prior use of immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies) with the last dose administered ≤ 30 days before enrollment;
. Severe surgery-related complications within 4 weeks postoperatively, including but not limited to: intra-abdominal infection requiring intravenous antibiotics for ≥ 7 days, enteric fistula requiring surgical repair, massive hemorrhage requiring transfusion ≥ 400 mL within 24 hours, severe adhesive intestinal obstruction requiring gastrointestinal decompression for ≥ 3 days;
. Active autoimmune disease, or a history of autoimmune disease currently requiring long-term (≥ 2 weeks) immunosuppressive therapy, including but not limited to: rheumatoid arthritis requiring prednisone ≥ 10 mg/day or equivalent immunosuppressants, systemic lupus erythematosus requiring hydroxychloroquine plus glucocorticoids, ulcerative colitis with acute flare within the past 1 year, multiple sclerosis with relapse within the past 2 years, autoimmune thyroiditis requiring high-dose levothyroxine \> 150 μg/day;
. Active infection within 1 month before enrollment, including but not limited to: Bacterial infections: pneumonia requiring intravenous antibiotics, pyelonephritis with positive urine culture and fever; Viral infections: HBsAg-positive with HBV DNA ≥ 1×10³ IU/mL (untreated); HCV RNA-positive (untreated with direct-acting antivirals or persistently positive after treatment); HIV-positive; acute varicella-zoster virus (VZV) or cytomegalovirus (CMV) infection with fever or organ involvement; Fungal infections: pulmonary candidiasis, aspergillosis (confirmed by imaging and positive fungal culture);
. Severe organ dysfunction or history thereof: acute myocardial infarction, unstable angina, heart failure (NYHA class ≥ II), severe arrhythmia (e.g., ventricular tachycardia requiring medication) within the past 6 months; uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite antihypertensive treatment); acute exacerbation of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis (CT-proven with FEV1/FVC \< 70% on pulmonary function testing), active pulmonary tuberculosis (positive sputum smear or strongly positive tuberculin test without completed standard anti-tuberculosis therapy); liver cirrhosis (Child-Pugh class B or higher), active hepatitis (ALT/AST \> 5×ULN), gastrointestinal bleeding within the past 1 year (e.g., esophagogastric variceal bleeding); chronic renal failure requiring dialysis or creatinine clearance \< 50 mL/min (calculated by Cockcroft-Gault formula), nephrotic syndrome (24-hour urinary protein \> 3.5 g);
. Uncontrolled diabetes mellitus (fasting blood glucose ≥ 11.1 mmol/L despite hypoglycemic agents); hyperthyroidism or hypothyroidism with free T3 and free T4 remaining outside the normal range despite medical treatment;