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BRAF V600 Mutation Positive MelanomaNCT06337617

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

An observational study of BRAF V600 Mutation Positive Melanoma, run by Novartis Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
BRAF V600 Mutation Positive Melanoma
How many people
90 participants
Where
1 siteChina
Study dates
10 May 2022to 29 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This was a retrospective, noninterventional cohort study.

Who may be able to join

  • 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

Who cannot join

  • None specified

Trial locations and contacts

1 site in 1 country.

China1 site

  • Novartis

    Shanghai, 201203

Other trials in China

About this study

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06337617
Study groupRoleWhat they receive
Cohort A (mucosal melanoma patients)Not described
Cohort B (non-mucosal melanoma patients)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-world overall response rate (rwORR)

    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.

    Measured: Up to approximately 2.6 years

Secondary outcomes (58)

  1. Mean Age

    Measured: Baseline

  2. Percentage of patients per sex

    Measured: Baseline

  3. Number of years of disease history at treatment initiation since initial melanoma diagnosis

    Measured: Baseline

  4. Number and percentage of patients per anatomic sites of origin

    Measured: Baseline

  5. Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis

    Measured: Baseline

  6. Number and percentage of patients per tumor stage

    Measured: Baseline

  7. Number and percentage of patients with occurrence of tumor metastasis

    Measured: Baseline

  8. Number and percentage of patients per metastatic location

    Measured: Baseline

  9. Number and percentage of patients per metastases

    Measured: Baseline

  10. Lactate dehydrogenase (LDH) levels

    Measured: Baseline

  11. Eastern Cooperative Oncology Group (ECOG) performance status

    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).

    Measured: Baseline

  12. Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment

    Measured: Baseline

  13. Number and percentage of patients per type of surgery

    Measured: Baseline

  14. Number and percentage of patients per name of surgery

    Measured: Baseline

  15. Number and percentage of patients per surgical and medical procedure

    Measured: Baseline

  16. Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment

    Measured: Baseline

  17. Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent

    Measured: Baseline

  18. Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting

    Measured: Baseline

  19. Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment

    Measured: Baseline

  20. Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type

    Measured: Baseline

  21. Number and percentage of patients per reason for immunotherapy discontinuation

    Measured: Baseline

  22. Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response

    Measured: Baseline

  23. Number and percentage of patients per prior anti-neoplastic drug for melanoma

    Measured: Baseline

  24. Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment

    Measured: Baseline

  25. Number and percentage of patients with prior radiotherapy for melanoma per treatment intent

    Measured: Baseline

  26. Number and percentage of patients with prior radiotherapy for melanoma per treatment setting

    Measured: Baseline

  27. Number and percentage of patients per radiation site

    Measured: Baseline

  28. Mean total dosage for all radiotherapy

    Measured: Baseline

  29. Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response

    Measured: Baseline

  30. Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment

    Measured: Up to approximately 2.2 years

  31. Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent

    Measured: Up to approximately 2.2 years

  32. Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting

    Measured: Up to approximately 2.2 years

  33. Number and percentage of patients per type of D+T treatment change

    Measured: Up to approximately 2.2 years

  34. Number and percentage of patients per reason for D+T treatment change

    Measured: Up to approximately 2.2 years

  35. Mean duration of D+T, if not ongoing to end of study follow-up

    Measured: Up to approximately 2.2 years

  36. rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS)

    Measured: Up to approximately 2.6 years

  37. Real-world disease control rate (rwDCR) of D+T (FAS)

    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.

    Measured: Up to approximately 2.6 years

  38. Real-world duration of response (rwDOR) of dabrafenib plus trametinib

    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.

    Measured: Up to approximately 2.6 years

  39. Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS)

    rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.

    Measured: Up to approximately 2.6 years

  40. Real-world overall survival (rwOS) since D+T initiation (FAS)

    rwOS was defined as the time from start of treatment to death due to any cause.

    Measured: Up to approximately 2.6 years

  41. Time to treatment discontinuation (FAS)

    Measured: Up to approximately 2.6 years

  42. Number and percentage of patients with adverse events of special interest (AESIs) (FAS)

    AESIs were defined based on the case retrieval strategy file available at the time of analysis.

    Measured: Up to approximately 2.6 years

  43. Number and percentage of patients with serious adverse events (SAEs) (FAS)

    Measured: Up to approximately 2.6 years

  44. rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use

    rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.

    Measured: Up to approximately 2.6 years

  45. rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use

    rwPFS was defined as the time from the start of treatment to the first documented disease progression or death due to any cause.

    Measured: Up to approximately 2.6 years

  46. rwOS since D+T initiation (MMS), by immunotherapy use

    rwOS was defined as the time from start of treatment to death due to any cause.

    Measured: Up to approximately 2.6 years

  47. rwOS since D+T initiation (NMS), by immunotherapy use

    rwOS was defined as the time from start of treatment to death due to any cause.

    Measured: Up to approximately 2.6 years

  48. Number and percentage of patients with systemic anti-neoplastic treatment after D+T

    Measured: Up to approximately 2.6 years

  49. Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment

    Measured: Up to approximately 2.6 years

  50. Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up

    Measured: Up to approximately 2.6 years

  51. Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type

    Measured: Up to approximately 2.6 years

  52. Number and percentage of patients per reason for immunotherapy discontinuation

    Measured: Up to approximately 2.6 years

  53. Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response

    Measured: Up to approximately 2.6 years

  54. Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment

    Measured: Up to approximately 2.6 years

  55. Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication

    Measured: Up to approximately 2.6 years

  56. Number and percentage of patients per concomitant medication

    Measured: Up to approximately 2.2 years

  57. Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS)

    Measured: Up to approximately 2.6 years

  58. Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use

    Measured: Up to approximately 2.6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start10 May 2022
  3. Primary completion29 Jun 2023
  4. Study completion29 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337617
Sponsor's protocol ID
CDRB436B2407
Status last verified
Mar 2024
First submitted
22 Mar 2024
Last updated
29 Mar 2024
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of BRAF V600 Mutation Positive Melanoma, run by Novartis Pharmaceuticals at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-world overall response rate (rwORR) (time frame: Up to approximately 2.6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06337617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.

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