Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT05510466
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-08-19', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison between intra and extra cerebral metastasis', 'timeFrame': 'day 1', 'description': 'comparison between intra and extra cerebral metastasis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Initially treated by a doubled targeted therapy anti BRAF/anti MEK', 'immunotherapy', 'combined tritherapy', "melanoma's brain metastasis", 'With an intra cerebral progression of the tumor'], 'conditions': ['Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Metastatic melanoma BRAF mutated\n* Initially treated by a doubled targeted therapy anti BRAF/anti MEK\n* With an intra cerebral progression of the tumor\n* Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy\n* between 01/2019 et 01/2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Metastatic melanoma BRAF mutated\n* Initially treated by a doubled targeted therapy anti BRAF/anti MEK\n* With an intra cerebral progression of the tumor\n* Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy\n* between 01/2019 et 01/2022\n\nExclusion criteria:\n\n\\- Other condition'}, 'identificationModule': {'nctId': 'NCT05510466', 'briefTitle': 'Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.', 'orgStudyIdInfo': {'id': 'RECHMPL22_0016'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier DEREURE, MD, PhD', 'role': 'CONTACT', 'email': 'o-dereure@chu-montpellier.fr', 'phone': '467336906', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Olivier DEREURE, MD, PhD', 'role': 'CONTACT', 'email': 'o-dereure@chu-montpellier.fr', 'phone': '467336906', 'phoneExt': '33'}, {'name': 'Marie Louise Jeanne, resident', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Marie Louise Jeanne, resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}