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Starting soon Phase 2/3

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

NCT06276504 · tracked via the Priya Life Science France tracker
Phase
Phase 2/3
Started
2024-04
Last updated
2024-02-26

Condition(s) studied

Progressive Multifocal Leukoencephalopathy

Investigational drug(s) / intervention(s)

Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years old 2. Diagnosis of definite PML since less than 2 months according to American Academy of Neurology 3. Presence of JCV in the CSF in the last CSF sampling. 4. Signed informed consent (from the patient, or if unable to consent, from a surrogate) 5. For women of childbearing potential: negative serum or urine b-HCG test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment) Exclusion Criteria: 1. Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases) 2. Patients who have received solid organ transplantation 3. Hypersensitivity to the active substance or to any of the excipients 4. Life expectancy less than 1 month 5. Pregnancy or lactating women or planning birth during the study period 6. Having previously been treated by anti-PD1mAb 7. Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion 8. Patient whose weight is \> 100kg 9. Participation in other interventional study \[a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if: * the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study * if this does not alter the study's ability to evaluate the effect of Pembrolizumab in terms of safety and efficacy (from the investigator's point of view)\] 10. Patient without national health insurance, and patient on AME (state medical aid) 11. Patient under guardianship or curatorship 12. Patient deprived of their liberty by a judicial or administrative decision

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)

FacilityCityRegionStatus
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
Official registry record

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