NCT06276504

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Multifocal Leukoencephalopathy

Interventions

Type	Name	Description
DRUG	Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection	Pembrolizumab administration at D0, M1 and M2

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

3 sites across 1 country: France