A randomized open-label multi-arm two-part phase II study to assess efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma

Brief description of study

The purpose of the study is to evaluate whether LXH254 may help overcome intrinsic and acquired resistance to BRAF targeted therapy and whether it can be effective in NRAS melanoma patients. LXH254 is a potent and selective adenosine triphosphate (ATP)-competitive inhibitor of the BRAF and CRAF protein kinases. The study drug LXH254 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial. The trial will assess the antitumor efficacy of LXH254 in combination with different agents. LXH254 will be evaluated in combination with trametinib, ribociclib, or LTT462, ERK1/2 kinase inhibitor.


Clinical Study Identifier: s20-00472
ClinicalTrials.gov Identifier: NCT04417621
Principal Investigator: Janice Mehnert.


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