Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04666272
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • dabrafenib — DRUG
    There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
  • trametinib — DRUG
    There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.

Study Details

This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.

Key Dates

Start date
Dec 31, 2020
Status verified
Feb 2026
Primary completion
Feb 4, 2028
Completion
Feb 4, 2028

Study Design

Enrollment
78 participants (actual)

Arms

  • Arm: dabrafenib in combination with trametinib as adjuvant treatment
    Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: Up to 36 months ]

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