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A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess the Efficacy and Safety of Multiple LXH254 Combinations in Patients with Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma
e primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma
1.The primary objective of this study is to evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR) by local investigator s assessment per RECIST v1.1 2.To characterize the safety and tolerability of each combination arm through the incidence and severity of AEs including changes in laboratory values, vital signs, cardiac assessment, dose interruptions, reduction and permanent discontinuations of study treatments. 3.To further evaluate the efficacy of each combination arm by duration of response (DOR), progression free survival (PFS) and disease control rate (DCR) using RECIST v1.1, per local assessment. Additionally, for the treatment combination arm(s) that expanded, DoR, PFS, DCR and ORR will be evaluated using RECIST v1.1 per central assessment. 4.To evaluate the overall survival (OS) of each combination arm To characterize the pharmacokinetics of each combination regimen through serum/plasma concentration and pharmacokinetic parameters of each combination regimen.
GSK1120212 (Trametinib); LEE011 (Ribociclib); LTT462 (); LXH254 (); Ribociclib (); Trametinib ()