nctId: NCT06337617 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 overallStatus: COMPLETED date: 2022-05-10 date: 2023-06-29 date: 2023-06-29 date: 2024-03-29 date: 2024-03-29 name: Novartis Pharmaceuticals class: INDUSTRY 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. conditions: BRAF V600 Mutation Positive Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 90 type: ACTUAL measure: Real-world overall response rate (rwORR) measure: Mean Age measure: Percentage of patients per sex measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis measure: Number and percentage of patients per anatomic sites of origin measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis measure: Number and percentage of patients per tumor stage measure: Number and percentage of patients with occurrence of tumor metastasis measure: Number and percentage of patients per metastatic location measure: Number and percentage of patients per metastases measure: Lactate dehydrogenase (LDH) levels measure: Eastern Cooperative Oncology Group (ECOG) performance status measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment measure: Number and percentage of patients per type of surgery measure: Number and percentage of patients per name of surgery measure: Number and percentage of patients per surgical and medical procedure measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting measure: Number and percentage of patients per radiation site measure: Mean total dosage for all radiotherapy measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting measure: Number and percentage of patients per type of D+T treatment change measure: Number and percentage of patients per reason for D+T treatment change measure: Mean duration of D+T, if not ongoing to end of study follow-up measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS) measure: Real-world disease control rate (rwDCR) of D+T (FAS) measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS) measure: Real-world overall survival (rwOS) since D+T initiation (FAS) measure: Time to treatment discontinuation (FAS) measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS) measure: Number and percentage of patients with serious adverse events (SAEs) (FAS) measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use measure: rwOS since D+T initiation (MMS), by immunotherapy use measure: rwOS since D+T initiation (NMS), by immunotherapy use measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type measure: Number and percentage of patients per reason for immunotherapy discontinuation measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication measure: Number and percentage of patients per concomitant medication measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS) measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Shanghai zip: 201203 country: China lat: 31.22222 lon: 121.45806 hasResults: False