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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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BRAF V600 Mutation Positive Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort A (mucosal melanoma patients)

No interventions assigned to this group

Cohort B (non-mucosal melanoma patients)

No interventions assigned to this group

Eligibility Criteria

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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