Phase II, Multi-center, Open-label Study of Single-agent LGX818 Followed by a Rational Combination With Agents After Progression on LGX818, in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma
This is a phase II two part multi-center, open-label study. Part I: LGX818 single agent
treatment until progression Part II: Combination treatments of LGX818 + MEK162, or BKM120,
or BGJ398, or INC280, or LEE01 to assess the clinical efficacy, to further evaluate the
safety of the drug combinations in patients with locally advanced or metastatic BRAF mutant
melanoma after relapse on LGX818, and to determine the maximum tolerated dose of the
combinations (when not established previously). These drug combinations are selected and
assigned to patients based on documentation of molecular resistance mechanism.
Patients with BRAF mutant melanoma treated by LGX818 single agent in other studies can be
enrolled directly in Part II of CLGX818X2102 after relapse.
Dose-escalations in the combination arms for which no MTD has been established will be based
on the recommendations of a Bayesian logistic regression model guided by an escalation with
overdose control criterion
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
United States: Food and Drug Administration