protocolSection identificationModule nctId: NCT06337617, orgStudyIdInfo id: CDRB436B2407, briefTitle: A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-10, primaryCompletionDateStruct date: 2023-06-29, completionDateStruct date: 2023-06-29, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record., conditionsModule conditions: BRAF V600 Mutation Positive Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Real-world overall response rate (rwORR), secondaryOutcomes measure: Mean Age, secondaryOutcomes measure: Percentage of patients per sex, secondaryOutcomes measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis, secondaryOutcomes measure: Number and percentage of patients per anatomic sites of origin, secondaryOutcomes measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis, secondaryOutcomes measure: Number and percentage of patients per tumor stage, secondaryOutcomes measure: Number and percentage of patients with occurrence of tumor metastasis, secondaryOutcomes measure: Number and percentage of patients per metastatic location, secondaryOutcomes measure: Number and percentage of patients per metastases, secondaryOutcomes measure: Lactate dehydrogenase (LDH) levels, secondaryOutcomes measure: Eastern Cooperative Oncology Group (ECOG) performance status, secondaryOutcomes measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients per type of surgery, secondaryOutcomes measure: Number and percentage of patients per name of surgery, secondaryOutcomes measure: Number and percentage of patients per surgical and medical procedure, secondaryOutcomes measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type, secondaryOutcomes measure: Number and percentage of patients per reason for immunotherapy discontinuation, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma, secondaryOutcomes measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting, secondaryOutcomes measure: Number and percentage of patients per radiation site, secondaryOutcomes measure: Mean total dosage for all radiotherapy, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting, secondaryOutcomes measure: Number and percentage of patients per type of D+T treatment change, secondaryOutcomes measure: Number and percentage of patients per reason for D+T treatment change, secondaryOutcomes measure: Mean duration of D+T, if not ongoing to end of study follow-up, secondaryOutcomes measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS), secondaryOutcomes measure: Real-world disease control rate (rwDCR) of D+T (FAS), secondaryOutcomes measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib, secondaryOutcomes measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS), secondaryOutcomes measure: Real-world overall survival (rwOS) since D+T initiation (FAS), secondaryOutcomes measure: Time to treatment discontinuation (FAS), secondaryOutcomes measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS), secondaryOutcomes measure: Number and percentage of patients with serious adverse events (SAEs) (FAS), secondaryOutcomes measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use, secondaryOutcomes measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use, secondaryOutcomes measure: rwOS since D+T initiation (MMS), by immunotherapy use, secondaryOutcomes measure: rwOS since D+T initiation (NMS), by immunotherapy use, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type, secondaryOutcomes measure: Number and percentage of patients per reason for immunotherapy discontinuation, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment, secondaryOutcomes measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication, secondaryOutcomes measure: Number and percentage of patients per concomitant medication, secondaryOutcomes measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS), secondaryOutcomes measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: Shanghai, zip: 201203, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False