NCT06276504RecruitingPhase 2
Pembrolizumab in progressive multifocal leukoencephalopathy (PML) in immunocompromised patients without HIV infection (PENALTY)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the efficacy of Pembrolizumab in terms of at least one negativation of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period, in immunocompromised patients with PML (with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 15 Jan 2025
- Lead sponsor
- Assistance Publique Hopitaux De Paris
- Diseases
- HIV
- EU CT number
- 2023-503520-31-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)]
Other illness
- 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
Other
- 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
- Life expectancy less than 1 month
- Pregnancy or lactating women or planning birth during the study period
- Patient whose weight is > 100kg
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.