Clinical trial NCT06337617: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRAF V600 Mutation Positive Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Cohorts A and B:

* Initiated dabrafenib and trametinib combination therapy (D+T) according to approved label between 01 May 2020 and 31 July 2022
* Was ≥18 years old of age at the initiation of D+T
* Had at least one tumor assessment after initiation of D+T
* Written informed consent if requested by the study site

Cohort A Only • Confirmed BRAF V600 mutation positive mucosal melanoma that was unresectable or metastatic

Cohort B Only

• Confirmed BRAF V600 mutation positive non-mucosal melanoma (cutaneous and acral melanoma) that was unresectable or metastatic

Exclusion Criteria:

None specified

Primary outcomes:
measure: Real-world overall response rate (rwORR)
timeFrame: Up to approximately 2.6 years
Secondary outcomes:
measure: Mean Age
timeFrame: Baseline
measure: Percentage of patients per sex
timeFrame: Baseline
measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis
timeFrame: Baseline
measure: Number and percentage of patients per anatomic sites of origin
timeFrame: Baseline
measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis
timeFrame: Baseline
measure: Number and percentage of patients per tumor stage
timeFrame: Baseline
measure: Number and percentage of patients with occurrence of tumor metastasis
timeFrame: Baseline
measure: Number and percentage of patients per metastatic location
timeFrame: Baseline
measure: Number and percentage of patients per metastases
timeFrame: Baseline
measure: Lactate dehydrogenase (LDH) levels
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: Baseline
measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment
timeFrame: Baseline
measure: Number and percentage of patients per type of surgery
timeFrame: Baseline
measure: Number and percentage of patients per name of surgery
timeFrame: Baseline
measure: Number and percentage of patients per surgical and medical procedure
timeFrame: Baseline
measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment
timeFrame: Baseline
measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent
timeFrame: Baseline
measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting
timeFrame: Baseline
measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment
timeFrame: Baseline
measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type
timeFrame: Baseline
measure: Number and percentage of patients per reason for immunotherapy discontinuation
timeFrame: Baseline
measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response
timeFrame: Baseline
measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma
timeFrame: Baseline
measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment
timeFrame: Baseline
measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent
timeFrame: Baseline
measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting
timeFrame: Baseline
measure: Number and percentage of patients per radiation site
timeFrame: Baseline
measure: Mean total dosage for all radiotherapy
timeFrame: Baseline
measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response
timeFrame: Baseline
measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment
timeFrame: Up to approximately 2.2 years
measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent
timeFrame: Up to approximately 2.2 years
measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting
timeFrame: Up to approximately 2.2 years
measure: Number and percentage of patients per type of D+T treatment change
timeFrame: Up to approximately 2.2 years
measure: Number and percentage of patients per reason for D+T treatment change
timeFrame: Up to approximately 2.2 years
measure: Mean duration of D+T, if not ongoing to end of study follow-up
timeFrame: Up to approximately 2.2 years
measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)
timeFrame: Up to approximately 2.6 years
measure: Real-world disease control rate (rwDCR) of D+T (FAS)
timeFrame: Up to approximately 2.6 years
measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib
timeFrame: Up to approximately 2.6 years
measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)
timeFrame: Up to approximately 2.6 years
measure: Real-world overall survival (rwOS) since D+T initiation (FAS)
timeFrame: Up to approximately 2.6 years
measure: Time to treatment discontinuation (FAS)
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS)
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with serious adverse events (SAEs) (FAS)
timeFrame: Up to approximately 2.6 years
measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use
timeFrame: Up to approximately 2.6 years
measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use
timeFrame: Up to approximately 2.6 years
measure: rwOS since D+T initiation (MMS), by immunotherapy use
timeFrame: Up to approximately 2.6 years
measure: rwOS since D+T initiation (NMS), by immunotherapy use
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients per reason for immunotherapy discontinuation
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication
timeFrame: Up to approximately 2.6 years
measure: Number and percentage of patients per concomitant medication
timeFrame: Up to approximately 2.2 years
measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)
timeFrame: Up to approximately 2.6 years
measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use
timeFrame: Up to approximately 2.6 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: