2024-514399-42-00招募中2 期
MATVAC-1 : EVALUATION OF UCPVAX VACCINE +/- PEMBROLIZUMAB COMBINED WITH STANDARD TREATMENT AS ADJUVANT THERAPY IN PATIENTS WITH UNMETHYLATED MGMT GLIOBLASTOMA
Centre Hospitalier Regional Universitaire4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年11月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- In each experimental arms, the primary endpoint for the efficacy is the rate of patients alive at 18 months post randomization
研究概览
简要总结
To assess the Overall Survival (OS) at 18 months since randomization of patients with GBM treated in the two experimental arms with UCPVax +/- pembrolizumab combined with standard treatment( Temozolomide +/- NovoTTF-200A)
研究设计
- 分配方式
- Randomized
- 主要目的
- Maintenance trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1 - Male or female, age ≥ 18 with informed consent signed
- •10- Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.
- •11- Patient affiliated to or beneficiary of French social security system
- •12- Ability to comply with the study protocol, in the Investigator’s judgment.
- •13- Signed and dates informed consent
- •2 - Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy).
- •3- Tumor with unmethylated MGMT promoter status
- •4- Patients having completed the concomitant phase of radiotherapy + temozolomide regimen, and eligible for the 6 monthly cycles of maintenance temozolomide
- •5- Karnofsky Perfomance status (KPS) ≥ 70%
- •6- Life expectancy ≥ 3 months
- •7- If patient is treated by corticosteroïds (CS), patient must be on stable CS dose for 15 days and total daily dose ≤ 10 mg prednisone, or equivalent
- •8- Adequate organ function laboratory values:
- •9- Females must be using highly effective contraceptive measures (see Section V-5-1), and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening : o Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments. o Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution. o Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
排除标准
- •1- IDH1 or IDH2 mutated tumor
- •18- Hypersensitivity to dacarbazine (DTIC )
- •19- Hypersensitivity to the active substance pembrolizumab or to any of the excipients listed (L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E433))
- •2- Presence of extracranial metastasis
- •20- Hypersensitivity to the active substance Montanide
- •21- Uncontrolled active systemic fungal, bacterial, viral, or other infection within the previous 4 weeks or requirement for intravenous (IV) antibiotics within the last two weeks
- •22- Inadequate hematology and organ functions; known cardiac failure or unstable coronaropathy, respiratory failure or another life threatening condition.
- •23- Patient with unresolved non-hematologic toxicities > Grade 1 (or > Grade 2 if deemed acceptable by the investigator and not considered a safety risk )
- •24- Major surgery within 1 month prior randomization or planned during the study
- •3- Leptomeningeal disease on MRI
- •4- Contrast enhancement ≥4 cm (largest diameter on axial T1 sequences) on inclusion MRI
- •10- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- •5- Previous treatment with Carmustine impregnated wafers (GliadelR)
- •6- Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists
- •7- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.
- •8- Prior therapy with an anti-PD-1, anti-PD-L1, or with an agent directed to another immune checkpoint (e.g. CTLA-4, TIGIT, Lag3…).
- •9- Immunosuppressive treatment including CS > 10 mg prednisone or equivalent within the previous 2 weeks
- •25- Vaccination with alive attenuated vaccine within 4 weeks prior the first dosing. Patient must agree not to receive live attenuated vaccine including influenza vaccine during the treatment and within 6 months following the last dose of pembrolizumab
- •11- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- •12- History of tuberculosis infection
- •13- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •14- Active auto-immune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroïds or immunosuppressors). Replacement therapy (e.g. thyroxine, insulin) is allowed.
- •15- Active or history of auto-immune disease or immune deficiency (see Appendix 7 for more details)
- •16- History of solid organ transplant nor allogenic hematopoietic stem cell transplantation
- •17- Hypersensitivity to the active substance temozolomide or to any of the excipients listed (anhydrous lactose, colloidal anhydrous silica, sodium carboxymethyl starch type A, tartaric acid, stearic acid),
结局指标
主要结局
In each experimental arms, the primary endpoint for the efficacy is the rate of patients alive at 18 months post randomization
In each experimental arms, the primary endpoint for the efficacy is the rate of patients alive at 18 months post randomization
次要结局
- The rate of patients alive at 18 months post randomization
- Overall survival (OS) defined as the time interval from randomization to the date of death from any cause. Alive patients will be censored at the last date known to be alive, either during study treatment period or during follow-up period
- Progression free survival (PFS) according to RANO 2.0 criteria: defined as the time interval from the date of randomization to the date of first documented disease progression or death from any cause, whichever occurs first. Alive patients without progression will be censored at last radiological evaluation showing no progression during study treatment follow-up.
- Adverse events and routine lab abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0, see Appendix 2), timing, seriousness and relationship to study treatments at each visit.
- Immunogenecity will be assess by ex vivo IFN-γ ELISpot in peripheral blood (Adotevi JCO 2023).
- Health related Quality of life will be evaluated with EORTC-QLQC30 questionnaire and BN20 module at randomization and at 6 months.
研究者
Marion JACQUIN
Scientific
Centre Hospitalier Regional Universitaire
研究点 (4)
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