Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

Novartis

Status: Completed

Conditions: BRAF V600 Mutated-Stage III/IV Melanoma

Study type: Observational

Funder types: Industry

Identifiers

NCT06557291

CTMT212AUS65

Details and patient eligibility

About

This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
• Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
• Documented local or central assay-positive for tumor BRAF V600E/K mutation.
• Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
• Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
• Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.

Exclusion criteria

• Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
• More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
• Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.

Trial design

38 participants in 1 patient group

Dabrafenib and Trametinib Combination Therapy Cohort

Description:

Adult BRAF V600 patients with resected stage III/IV melanoma that relapsed during or after CPI as their first adjuvant therapy and were again rendered free of disease and received adjuvant dab/tram combination therapy.