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

Completed

Conditions studied: BRAF V600 Mutated-Stage III/IV Melanoma

In brief

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.

Key facts

Study ID

NCT06557291

Run by

Novartis

People needed

38

Starts

2022-10-04

Expected to finish

2023-11-16

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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