Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection: Pembrolizumab administration at D0, M1 and M2
Study 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.
Eligibility
Primary outcome measure(s)
- 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 — At baseline (Day 0), 1 month, 2 months and 3 months
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06276504 on ClinicalTrials.gov ↗ ← All trials in France