Pembrolizumab in progressive multifocal leukoencephalopathy (PML) in immunocompromised patients without HIV infection (PENALTY)

Phase 1

Active, not recruiting

• Conditions: 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).; MedDRA version: 20.1Level: PTClassification code: 10036807Term: Progressive multifocal leukoencephalopathy Class: 100000004862; MedDRA version: 20.0Level: SOCClassification code: 10021881Term: Infections and infestations Class: 1; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-503520-31-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 33

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), 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, 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)]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified