A Phase 2/3 interventional study of Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection in Progressive Multifocal Leukoencephalopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
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.
29 studies on the registry are indexed under Leukoencephalopathy, Progressive Multifocal; 7 are open to participants now.
This study's planned enrollment of 33 is above the median of 24 across 15 interventional studies indexed under Leukoencephalopathy, Progressive Multifocal.
Browse Leukoencephalopathy, Progressive Multifocal studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pembrolizumab (commercial name: KEYTRUDA; MSD), 25 mg/ml solution for intravenous (IV) injection
Drug: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection
Drug page: Pembrolizumab
Pembrolizumab administration at D0, M1 and M2
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
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF)
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Repositivation of JCV PCR: at least a positive result following at least a negative result
Time frame: At baseline (Day 0), 1 month, 2 months and 3 months
Evolution of National Institutes of Health Stroke Scale (NIHSS) score
Repeated measures of neurological status
Time frame: At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months
Evolution of 6-item Modified Rankin Scale score (includes death as most severe state)
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
Evolution of Glasgow Outcome Scale Extended (GOS-E) score
Repeated measures of neurological outcome and degree of disability in neurological conditions
Time frame: At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months
Relapse or progression
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
Death (and date of death)
Time frame: From baseline to end of participation, a maximum of 12 months
Cause specific death: death related to PML
Adjudication by a dedicated committee
Time frame: From baseline to end of participation, a maximum of 12 months
Any adverse event classified by using US NCI CTCAE
Time frame: From baseline to end of participation, a maximum of 12 months
Plan to share: Yes — The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Apr 2028, 48 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pembrolizumab
Leukoencephalopathy, Progressive Multifocal →
Assistance Publique - Hôpitaux de Paris →