Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 11:16 AM
Study NCT ID:
NCT06276504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007968', 'term': 'Leukoencephalopathy, Progressive Multifocal'}], 'ancestors': [{'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months and 3 months'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months and 3 months'}, {'measure': 'Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF)', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months and 3 months'}, {'measure': 'Repositivation of JCV PCR: at least a positive result following at least a negative result', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months and 3 months'}, {'measure': 'Evolution of National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months', 'description': 'Repeated measures of neurological status'}, {'measure': 'Evolution of 6-item Modified Rankin Scale score (includes death as most severe state)', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months', 'description': 'Repeated measures of degree of disability or dependence in the daily activities in neurological conditions'}, {'measure': 'Evolution of Glasgow Outcome Scale Extended (GOS-E) score', 'timeFrame': 'At baseline (Day 0), 1 month, 2 months, 3 months, 6 months, and 12 months', 'description': 'Repeated measures of neurological outcome and degree of disability in neurological conditions'}, {'measure': 'Relapse or progression', 'timeFrame': 'From baseline to end of participation, a maximum of 12 months', 'description': 'Adjudication by a dedicated committee ; based on clinical evolution, JCV PCR in CSF, brain MRI'}, {'measure': 'Death (and date of death)', 'timeFrame': 'From baseline to end of participation, a maximum of 12 months'}, {'measure': 'Cause specific death: death related to PML', 'timeFrame': 'From baseline to end of participation, a maximum of 12 months', 'description': 'Adjudication by a dedicated committee'}, {'measure': 'Any adverse event classified by using US NCI CTCAE', 'timeFrame': 'From baseline to end of participation, a maximum of 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progressive Multifocal Leukoencephalopathy', 'Checkpoint inhibitors', 'Pembrolizumab'], 'conditions': ['Progressive Multifocal Leukoencephalopathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Diagnosis of definite PML since less than 2 months according to American Academy of Neurology\n3. Presence of JCV in the CSF in the last CSF sampling.\n4. Signed informed consent (from the patient, or if unable to consent, from a surrogate)\n5. 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)\n\nExclusion Criteria:\n\n1. Patients in whom immune reconstitution is achievable (HIV infection - Multiple sclerosis - Auto-immune and inflammatory diseases)\n2. Patients who have received solid organ transplantation\n3. Hypersensitivity to the active substance or to any of the excipients\n4. Life expectancy less than 1 month\n5. Pregnancy or lactating women or planning birth during the study period\n6. Having previously been treated by anti-PD1mAb\n7. Patient receiving IL-2 or IL-7 for the treatment of PML at inclusion\n8. Patient whose weight is \\> 100kg\n9. 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:\n\n * the investigational treatment has been completed and there is no risk of drug interaction with the administration of Pembrolizumab as defined in PENALTY study\n * 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)\\]\n10. Patient without national health insurance, and patient on AME (state medical aid)\n11. Patient under guardianship or curatorship\n12. Patient deprived of their liberty by a judicial or administrative decision"}, 'identificationModule': {'nctId': 'NCT06276504', 'acronym': 'PENALTY', 'briefTitle': 'Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection', 'orgStudyIdInfo': {'id': 'APHP211001'}, 'secondaryIdInfos': [{'id': '2023-503520-31-00', 'type': 'OTHER', 'domain': 'EU CT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab', 'description': 'Pembrolizumab (commercial name: KEYTRUDA; MSD), 25 mg/ml solution for intravenous (IV) injection', 'interventionNames': ['Drug: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection']}], 'interventions': [{'name': 'Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection', 'type': 'DRUG', 'description': 'Pembrolizumab administration at D0, M1 and M2', 'armGroupLabels': ['Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Nicolas WEISS, Pr', 'role': 'CONTACT', 'email': 'nicolas.weiss@aphp.fr', 'phone': '+33 (0)1 42 16 27 70'}], 'facility': 'Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Damien ROOS-WEIL, Dr', 'role': 'CONTACT', 'email': 'damien.roosweil@aphp.fr', 'phone': '+33 (0)1 42 16 15 96'}], 'facility': "Hôpital Pitié-Salpêtrière - Service d'hématologie clinique", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Valérie POURCHER, Pr', 'role': 'CONTACT', 'email': 'valerie.martinez@aphp.fr', 'phone': '+33 (0)1 42 16 02 62'}], 'facility': 'Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Valérie POURCHER, Pr', 'role': 'CONTACT', 'email': 'valerie.martinez@aphp.fr', 'phone': '+33 (0)1 42 16 02 62'}, {'name': 'TUBACH Florence, Pr', 'role': 'CONTACT', 'email': 'urc.pslcfx.psl@aphp.fr', 'phone': '+33 (0)1 42 16 05 05'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "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.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}