Testing pembrolizumab in people with PML who have weakened immune systems
Tests pembrolizumab in adults with a brain infection called PML and weakened immunity.
Plain-language title generated from the registry record
Registry title: Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
Key facts
- Where
- Clermont-Ferrand, Nantes, Paris, Paris Cedex 13, and Toulouse, FranceSee the 5 sites
- Phase
- Phase 2/3
Where in France
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06276504EU 2023-503520-31-00
- Record updated
- 26 February 2024
- Original description
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.Read full original descriptionShow less
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
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.
Inclusion: Age ≥ 18 years old; Diagnosis of definite PML since less than 2 months according to American Academy of Neurology; Presence of JCV in the CSF in the last CSF sampling; Signed informed consent (from the patient, or if unable to consent, from a surrogate); 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: Patients who have received solid organ transplantation; Having previously been treated by anti-PD1mAb; Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion; 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)]; Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases); Hypersensitivity to the active substance or to any of the excipients; Life expectancy less than 1 month; Pregnancy or lactating women or planning birth during the study period; Patient whose weight is > 100kg; Patient without national health insurance, and patient on AME (state medical aid); Patient under guardianship or curatorship; Patient deprived of their liberty by a judicial or administrative decision.