Status:
COMPLETED
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
Lead Sponsor:
Novartis
Conditions:
BRAF V600 Mutated-Stage III/IV Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 4 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06557291
Start Date
October 4 2022
End Date
November 16 2023
Last Update
August 16 2024
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936