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Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection — PENALTY  

Progressive Multifocal Leukoencephalopathy Clinical Trial

Official title:
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06276504
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Valérie POURCHER, Pr
Phone +33 (0)1 42 16 02 62
Email valerie.martinez@aphp.fr
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date April 2024
Completion date April 2028
View Details
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