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Completed

NCT Number: 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

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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Key information

Conditions

BRAF V600 Mutation Positive Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Shanghai, 201203, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Age

    Time frame: Baseline

  2. Percentage of patients per sex

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

  6. Number and percentage of patients per tumor stage

    Time frame: Baseline

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

    Time frame: Baseline

  8. Number and percentage of patients per metastatic location

    Time frame: Baseline

  9. Number and percentage of patients per metastases

    Time frame: Baseline

  10. Lactate dehydrogenase (LDH) levels

    Time frame: Baseline

  11. 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).

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

    Time frame: Baseline

  13. Number and percentage of patients per type of surgery

    Time frame: Baseline

  14. Number and percentage of patients per name of surgery

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

  27. Number and percentage of patients per radiation site

    Time frame: Baseline

  28. Mean total dosage for all radiotherapy

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.2 years

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

    Time frame: Up to approximately 2.6 years

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. Time to treatment discontinuation (FAS)

    Time frame: Up to approximately 2.6 years

  42. 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.

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

    Time frame: Up to approximately 2.6 years

  44. 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.

  45. 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.

  46. 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.

  47. 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.

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

    Time frame: Up to approximately 2.6 years

  49. 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

  50. 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

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

    Time frame: Up to approximately 2.6 years

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

    Time frame: 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

    Time frame: Up to approximately 2.6 years

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

    Time frame: Up to approximately 2.6 years

  55. 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

  56. Number and percentage of patients per concomitant medication

    Time frame: Up to approximately 2.2 years

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

    Time frame: 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

    Time frame: Up to approximately 2.6 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.