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    Association details:
    Biomarker:BRAF mutation
    Cancer:Melanoma
    Drug:Mekinist (trametinib) (MEK inhibitor) +
    Tafinlar (dabrafenib) (BRAF inhibitor) +
    navitoclax (ABT 263) (Bcl2 inhibitor, Bcl-xL inhibitor, Bcl-w inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma

    Excerpt:
    ...Change in terminal deoxynucleotidyl transferase 2´-deoxyuridine, 5´-triphosphate (dUTP) nick end labeling assay (TUNEL) staining`Change in B-cell chronic lymphocytic leukemia/lymphoma 2 (BCL-2)`Change in Ki67`Change in phosphatase and tensin homolog (PTEN) status`Fold changes in BRAF-mutation assay`Fold changes in tumor burden`Pharmacokinetic parameters, including maximal plasma or serum concentration (Cmax), area under the curve to the last collection point (AUClast), area under the curve for dose interval (AUC0-t), and time of maximal concentration (Tmax)...
    Trial ID:
    NCI-2013-02103
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Randomized phase II trial of dabrafenib and trametinib with or without navitoclax in patients (pts) with BRAF-mutant (MT) metastatic melanoma (MM) (CTEP P9466).

    Published date:
    05/31/2023
    Excerpt:
    In pts with BRAF MT MM, DTN was associated with a CR rate of 20% and ORR of 84%. There was a trend for improved OS in pts treated with DTN compared to DT; the difference in OS was significant in pts with smaller tumor burden. The DTN regimen may be considered for further exploration in the post-ICI setting. Updated data on survival and translational studies will be presented.
    DOI:
    10.1200/JCO.2023.41.16_suppl.9511
    Trial ID:
    NCI-2013-02103
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2023
    Title:

    Randomized phase II trial of dabrafenib and trametinib with or without navitoclax in patients (pts) with BRAF-mutant (MT) metastatic melanoma (MM) (CTEP P9466).

    Published date:
    05/25/2023
    Excerpt:
    In pts with BRAF MT MM, DTN was associated with a CR rate of 20% and ORR of 84%. There was a trend for improved OS in pts treated with DTN compared to DT...
    DOI:
    10.1200/JCO.2023.41.16_suppl.9511
    Trial ID:
    NCI-2013-02103