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

March 22, 2024 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201203
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort A (mucosal melanoma patients)
Cohort B (non-mucosal melanoma patients)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Real-world overall response rate (rwORR)
Time Frame: Up to approximately 2.6 years
ORR was defined as the percentage of patients demonstrating a best overall response as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or as documented per physician assessment, as available.
Up to approximately 2.6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Age
Time Frame: Baseline
Baseline
Percentage of patients per sex
Time Frame: Baseline
Baseline
Number of years of disease history at treatment initiation since initial melanoma diagnosis
Time Frame: Baseline
Baseline
Number and percentage of patients per anatomic sites of origin
Time Frame: Baseline
Baseline
Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis
Time Frame: Baseline
Baseline
Number and percentage of patients per tumor stage
Time Frame: Baseline
Baseline
Number and percentage of patients with occurrence of tumor metastasis
Time Frame: Baseline
Baseline
Number and percentage of patients per metastatic location
Time Frame: Baseline
Baseline
Number and percentage of patients per metastases
Time Frame: Baseline
Baseline
Lactate dehydrogenase (LDH) levels
Time Frame: Baseline
Baseline
Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame: Baseline
ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Scores can range from a lower value of 0 (fully active, able to carry on all pre-disease performance without restriction) up to 5 (dead).
Baseline
Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment
Time Frame: Baseline
Baseline
Number and percentage of patients per type of surgery
Time Frame: Baseline
Baseline
Number and percentage of patients per name of surgery
Time Frame: Baseline
Baseline
Number and percentage of patients per surgical and medical procedure
Time Frame: Baseline
Baseline
Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment
Time Frame: Baseline
Baseline
Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent
Time Frame: Baseline
Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting
Time Frame: Baseline
Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment
Time Frame: Baseline
Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type
Time Frame: Baseline
Baseline
Number and percentage of patients per reason for immunotherapy discontinuation
Time Frame: Baseline
Baseline
Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response
Time Frame: Baseline
Baseline
Number and percentage of patients per prior anti-neoplastic drug for melanoma
Time Frame: Baseline
Baseline
Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment
Time Frame: Baseline
Baseline
Number and percentage of patients with prior radiotherapy for melanoma per treatment intent
Time Frame: Baseline
Baseline
Number and percentage of patients with prior radiotherapy for melanoma per treatment setting
Time Frame: Baseline
Baseline
Number and percentage of patients per radiation site
Time Frame: Baseline
Baseline
Mean total dosage for all radiotherapy
Time Frame: Baseline
Baseline
Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response
Time Frame: Baseline
Baseline
Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Number and percentage of patients per type of D+T treatment change
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Number and percentage of patients per reason for D+T treatment change
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Mean duration of D+T, if not ongoing to end of study follow-up
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Real-world disease control rate (rwDCR) of D+T (FAS)
Time Frame: Up to approximately 2.6 years
rwDCR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or non-CR or non-progressive disease (non-PD), per RECIST version 1.1 or as documented per physician assessment, as available.
Up to approximately 2.6 years
Real-world duration of response (rwDOR) of dabrafenib plus trametinib
Time Frame: Up to approximately 2.6 years
For the subset of patients with CR or PR, rwDORn was defined as the time from the date of the first documented CR or PR per RECIST version 1.1 or as documented per physician assessment as available, to the first disease progression or death due to any cause.
Up to approximately 2.6 years
Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)
Time Frame: Up to approximately 2.6 years
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Up to approximately 2.6 years
Real-world overall survival (rwOS) since D+T initiation (FAS)
Time Frame: Up to approximately 2.6 years
rwOS was defined as the time from start of treatment to death due to any cause.
Up to approximately 2.6 years
Time to treatment discontinuation (FAS)
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients with adverse events of special interest (AESIs) (FAS)
Time Frame: Up to approximately 2.6 years
AESIs were defined based on the case retrieval strategy file available at the time of analysis.
Up to approximately 2.6 years
Number and percentage of patients with serious adverse events (SAEs) (FAS)
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use
Time Frame: Up to approximately 2.6 years
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Up to approximately 2.6 years
rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use
Time Frame: Up to approximately 2.6 years
rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.
Up to approximately 2.6 years
rwOS since D+T initiation (MMS), by immunotherapy use
Time Frame: Up to approximately 2.6 years
rwOS was defined as the time from start of treatment to death due to any cause.
Up to approximately 2.6 years
rwOS since D+T initiation (NMS), by immunotherapy use
Time Frame: Up to approximately 2.6 years
rwOS was defined as the time from start of treatment to death due to any cause.
Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients per reason for immunotherapy discontinuation
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Number and percentage of patients per concomitant medication
Time Frame: Up to approximately 2.2 years
Up to approximately 2.2 years
Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years
Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use
Time Frame: Up to approximately 2.6 years
Up to approximately 2.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDRB436B2407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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