Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2024-04
Completion Date
2028-04
Last Updated
2024-02-26
Healthy Volunteers
No
Interventions
Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection
Pembrolizumab administration at D0, M1 and M2
Locations (3)
Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation
Paris, France
Hôpital Pitié-Salpêtrière - Service d'hématologie clinique
Paris, France
Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales
Paris, France