Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients W… (NCT06276504) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
France33 participantsStarted 2024-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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
What they're measuring
1
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
Timeframe: At baseline (Day 0), 1 month, 2 months and 3 months