Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-31 @ 9:59 AM
Study NCT ID:
NCT05806268
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2023-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of clinical predictors for choice of first-line (1L) therapy between dab/tram and enco/bini', 'timeFrame': 'Up to approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients receiving enco/bini or dab/tram in the 1L of therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Percentage of patients switching from 1L enco/bini therapy to either another targeted therapy (TT) or second-line (2L) immunotherapy (IO)', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Percentage of patients switching from 1L dab/tram therapy to either another TT or IO 2L therapy', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Percentage of patients who discontinued treatment in 1L and associated reasons, overall and by cohort', 'timeFrame': 'Up to approximately 2 years'}]}, 'conditionsModule': {'conditions': ['BRAF v600 Mutated Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \\& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation.\n\nNo quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Diagnosis of melanoma (ICD-9 172.x \\& ICD-10 C43 or D03x)\n* Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011\n* 1L treatment with enco/bini or dab/tram on or after 01 June 2018\n* Evidence of a BRAF test\n* Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation\n* At least 18 years of age at the time of initiation of 1L treatment Exclusion criteria\n* Documented receipt of a clinical trial treatment for cancer at any time on or after September 2015\n* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment'}, 'identificationModule': {'nctId': 'NCT05806268', 'briefTitle': 'Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients', 'orgStudyIdInfo': {'id': 'CTMT212AUS58'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dab/tram', 'description': 'Patients received dabrafenib and trametinib treatment'}, {'label': 'Enco/bini', 'description': 'Patients received encorafenib and binimetenib treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}