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NOT YET RECRUITING
NCT06276504
PHASE2/PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

DRUG

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