NCT06276504尚未招募2 期
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period
研究概览
简要总结
This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Diagnosis of definite PML since less than 2 months according to American Academy of Neurology
- •Presence of JCV in the CSF in the last CSF sampling.
- •Signed informed consent (from the patient, or if unable to consent, from a surrogate)
- •For women of childbearing potential: negative serum or urine b-HCG test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment)
排除标准
- •Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases)
- •Patients who have received solid organ transplantation
- •Hypersensitivity to the active substance or to any of the excipients
- •Life expectancy less than 1 month
- •Pregnancy or lactating women or planning birth during the study period
- •Having previously been treated by anti-PD1mAb
- •Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion
- •Patient whose weight is > 100kg
- •Participation in other interventional study [a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if:
- •the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study
- •if this does not alter the study's ability to evaluate the effect of Pembrolizumab in terms of safety and efficacy (from the investigator's point of view)]
- •Patient without national health insurance, and patient on AME (state medical aid)
- •Patient under guardianship or curatorship
- •Patient deprived of their liberty by a judicial or administrative decision
研究组 & 干预措施
Pembrolizumab
Experimental
Pembrolizumab (commercial name: KEYTRUDA; MSD), 25 mg/ml solution for intravenous (IV) injection
干预措施: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection (Drug)
结局指标
主要结局
Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period
时间窗: At baseline (Day 0), 1 month, 2 months and 3 months
次要结局
- Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event(At baseline (Day 0), 1 month, 2 months and 3 months)
- Any adverse event classified by using US NCI CTCAE(From baseline to end of participation, a maximum of 12 months)
- Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF)(At baseline (Day 0), 1 month, 2 months and 3 months)
- Repositivation of JCV PCR: at least a positive result following at least a negative result(At baseline (Day 0), 1 month, 2 months and 3 months)
- Evolution of National Institutes of Health Stroke Scale (NIHSS) score(At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months)
- Evolution of 6-item Modified Rankin Scale score (includes death as most severe state)(At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months)
- Evolution of Glasgow Outcome Scale Extended (GOS-E) score(At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months)
- Relapse or progression(From baseline to end of participation, a maximum of 12 months)
- Death (and date of death)(From baseline to end of participation, a maximum of 12 months)
- Cause specific death: death related to PML(From baseline to end of participation, a maximum of 12 months)
研究者
研究点 (3)
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