Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection
DrugPembrolizumab administration at D0, M1 and M2
NCT Number: NCT06276504
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation, Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pembrolizumab administration at D0, M1 and M2
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Time frame: At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months
Repeated measures of neurological status
Time frame: At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months
Repeated measures of degree of disability or dependence in the daily activities in neurological conditions
Time frame: At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months
Repeated measures of neurological outcome and degree of disability in neurological conditions
Time frame: From baseline to end of participation, a maximum of 12 months
Adjudication by a dedicated committee ; based on clinical evolution, JCV PCR in CSF, brain MRI
Time frame: From baseline to end of participation, a maximum of 12 months
Time frame: From baseline to end of participation, a maximum of 12 months
Adjudication by a dedicated committee
Time frame: From baseline to end of participation, a maximum of 12 months
Contact information is provided by the study sponsor or research team.
TUBACH Florence, Pr
CONTACT
Valérie POURCHER, Pr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PENALTY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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